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A Checklist for Optimizing Clinical Trial Study Startup Activities

• Frank Conte Vice President, Strategic Partnerships;

Study startup is a complicated, multi-faceted, and time-consuming component of the clinical research lifecycle, one notoriously prone to delays. The key challenge of successful, timely study startup requires careful coordination across multiple constituencies within and external to a research organization. As a result, it is easy to lose track of all the various steps necessary to activate a study efficiently and compliantly.   

With this in mind, we have outlined a checklist for researchers who are looking for guidance on study startup activities. We’ve included suggestions for optimizing each step to minimize delays and set your study on a clear path for success.    

About This List  

Careful planning from day one is essential for study success. The primary goal is to reduce the amount of time and resources required to activate a study.   Lists of various study startup activities vary widely depending on the level of detail provided. These elements are most critical and demand the most attention from sponsors, contract research organizations (CROs), monitors, and sites.  

Key Stakeholders  

Sponsors: The trial sponsor is primarily responsible for many study startup activities including but not limited to :   

• Writing the protocol  
• Funding and managing the budget for the study  
• Engaging a CRO to assist in the execution of the trial  
• Overseeing startup activities  
• Collecting, storing, and submitting the data and documents associated with the trial  

CROs: Some sponsors may involve a CRO to manage components of the study. Typically, CROs are respons ible for :   

• Budget negotiation  
• Engaging and selecting sites  
• Identifying patient populations and supporting recruitment  
• Overseeing training, conduct, and other processes across the study  

Monitors: Typically affiliated with the sponsor, monitors ensure appropriate and safe study conduct, as well as overseeing the progress of activating a study. Whether they monitor remotely or in person, they require detailed access to key study documents, standard operating procedures (SOPs), and more at each research site involved in the study.   

Research sites: S taff and investigators at the research site play a critical role in planning and conducting a clinical trial. They are responsible for but not limited to:   

• Conducting clinical trial visits and procedures  
• Collecting data during the visit  
• Connecting with patients to recruit and retain participa nts  
• Securing oversight committee approvals (IRB, IBC, SRC, RSC, COI, feasibility)  
• Executing billing and financial workflows to maintain operations and compliance  
• Communicating information to study stakeholders include status updates, essential protocol documents, and more  

1. Sponsors: Design and Optimize Your Protocol  

The clinical trial protocol organizes and dictates every component of study conduct. While each detail of the protocol is essential to study success, it also must holistically and realistically support study outcome goals. While many believe study startup is entirely reactive to the protocol, optimizing the protocol before it is ever in motion can greatly impact trial success. This may include reevaluating inclusion and exclusion criteria, enrollment goals, complicated or costly procedures, or other components.  

Early conversations with sites and patient groups will help ensure the visits and procedures are reasonable and achievable as study theory moves to the real-life setting.  

2. Sponsors : Build Your Budget  

Regardless of the type of study you are planning, building the budget is step one. You must get a handle on all the costs for activities happening throughout the life of the trial. Now is the time to thoroughly consider all the potential tasks and associated fees required. Consider the following:  

• Do you need help writing the protocol?   
• Do you need a data monitoring committee?   
• Do you need endpoint adjudication?   
• Do you need assistance or consulting help on any other matter?   
• Do you need specific technology to collect or exchange data across stakeholders?   

All of these, and many others, will impact your study’s budget and should be accounted for at the outset.  

Let data inform your budget building process. Explore our resource: Study Activation Survey Results: Budget Negotiation  

3. Sponsors and Sites : Submit Materials to Your IRB for Approval  

Partnering with an experienced IRB increases opportunities to streamline the activation process. As you’re beginning your partnership with your IRB, setting clear expectations for each organization is beneficial during study startup and will also help maintain the relationship for future studies.  

Setting up a study kickoff call can ensure any key milestones or special requirements are understood. Scheduling this conversation upfront with an IRB will save both the sponsor and IRB time during review time.  

Need additional guidance on review requirements?   

• Local Versus Central IRBs: What’s the Difference?  
• What Level of Review Does Your Study Need?  
• Does This Study Require IBC Review?  
• The Value of Early Engagement with Your IRB

4. Sponsors and CROs : Identify the Right Sites for Your Study  

To streamline startup activities, it is important to identify the most efficient and appropriate sites to conduct your study while your team might have a great relationship with a physician at a particular institution, it does not mean they have the appropriate patient population to achieve enrollment goals for the trial, or their institution has the resources to efficiently launch and run a study.   

Unfortunately, finding sites is a perennial problem—mostly because it is difficult to identify and connect with sites with the appropriate patient population for a study. Or once found, the sites are shown to lack sufficient staffing or resources to take on additional trials.   

More than a list of sites, Advarra’s SiteIQ solution provides detailed site performance metrics synthesized from actual completed studies, providing performance metrics and insights.  

5. Sponsors, CROs, and Sites : Conduct Feasibility Evaluation  

Protocol feasibility is the process of reviewing clinical trial logistics to determine if the site’s available resources are sufficient for trial conduct.

Site selection is informed early and most significantly by the feasibility questionnaire, a survey sent to all prospective sites. But if those questionnaires are deployed blindly to sites before diligent site planning occurs, it can result in responses failing to tell sponsors enough about the site’s feasibility for that specific protocol. 

A feasibility evaluation should include:  

• Financial viability  
• Available resources  
• Past performance and ability to accrue  
• Alignment with the study timeline  
• Current staffing and turnover  
• Competing trials and populations  

Sites are also responsible for completing and returning site feasibility questionnaires to inform selection and identify opportunities to take part in new studies. However, many questionnaires are redundant, or may not accurately capture a site’s ability to successfully conduct a study.   

6. Sponsors and Monitors : Conduct Pre-study Site Visits/Screening Visits  

Pre-study visits are the final and most crucial step in selecting appropriate sites. These visits are especially vital in cases where the research team has had no prior experience with the site.  

7. Sponsors and Sites : Initiate and Negotiate the Clinical Trial Agreement (CTA)  

The CTA is a legally binding agreement executed between sponsors and sites; one meant to protect both parties’ rights and interests. It covers delegation of responsibilities, obligations, allocation of risk, and financial commitments. Expect negotiations around this critical document and allocate time for them.  

8. Sponsors and Sites : Collect and Exchange Regulatory Documents and Critical Submissions  

Collecting and exchanging what are sometimes called the “essential” documents of the study startup process, is another place where teams will typically encounter issues slowing their progress, especially as these documents are numerous and complex. They fall into three general categories:   

• Federal/National Regulatory (i.e. FDA-USA, BfArM-Germany)  
• Institutional review board (IRB)/ethics committee (EC) submissions  
• SOP requirements  

Optimizing this process centers on removing redundancies and centralizing communication and exchange. For sponsors, leverage a centralized location – like in Advarra’s Longboat Platform – to distribute, monitor, and retrieve documents across your sites globally. Centralization also minimizes requests for redundant information, or for documents you’ve already received like CV’s, training certificates, and more.   

For sites, it is important to leverage site-centric technology connected with the sponsor to ensure you’re receiving essential study communications like protocol amendments or updated informed consent forms (ICFs) . By bringing your own technology to this critical step in study startup, you can maximize internal workflows when deploying documents to internal teams like quickly routing for investigator signatures and sign off, as well as returning documents quickly back to the sponsor

Learn more about how Advarra is streamlining document exchange across sites, CROs, and sponsors.  

9. Sponsors and Sites : Deploy and Complete Training  

Before a study begins enrollment, all relevant site staff must receive training and completely understand their roles. Any misunderstanding—or a lack of understanding—among site staff is a main contributor to delaying study startup progress or increasing timelines due to protocol deviations. Make sure your clinical team members thoroughly understand all the procedures, clinical and administrative, required of them by providing engaging and efficient training for each study.   

 Explore more resources on training best practices.  

Tagged in: CRO , institutions , sites , sponsors

Back to Resources

Dive Deeper into Study Startup Optimization  

Amid a million reasons for delays, there are always opportunities to improve and optimize study startup. In our white paper, ‘Expedite Study Startup: Four Strategies to Optimize Site Activation’ we will outline how organizations can expedite study startup through streamlining site selection, training, ethics review, and site initiation.  

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Tools and Techniques for Effective Clinical Research Start-up at an Academic Medical Center

Abstract : Activating a clinical research project at an academic medical center requires significant planning and effort from study teams. Research sponsors often have difficulty understanding any process lacking in consistency and transparency and so start-up becomes a barrier to study enrollment. This article breaks down such barriers by advocating specific project management and communication tools and techniques that accelerate the study start-up process without sacrificing quality.

Declaring Goals for Study Start-up

Study start-up is the project calibration stage of any clinical research project. There are many rules, regulations, and processes to be followed when conducting clinical research, and so it is essential to first have a strategy for successful completion of a project.

Table 1 highlights the goals for study start-up. From the onset, it is necessary for stakeholders to have a clear understanding of the institutional process as well as the more local program-specific process for study start-up. Individual program areas have their own priorities, so even within the same academic medical center, the start-up can take on a variety of forms, often for good reason. If it is difficult to create a one-size-fits-all model, it is then necessary to cultivate a flexible predictability via organizational consensus, staff training and education, and clear and regular communication with sponsors. Striving to meet sponsor expectations while executing organizational mandates are key objectives during start-up.

Identifying Barriers to Study Start-up

Executing on institutional mandates and minimizing the duration of study start-up are not mutually exclusive goals, but the interplay is often complicated. Institutional mandates account for sound legal, safety, and financial considerations. Study teams must be empowered to promote and act on these goals while also advocating for the priorities of clinical investigators and sponsors who wish to partner on a study.

There can be a lack of predictability in study start-up (Table 2). Portfolio complexity can be a barrier to site activation. For example, UCLA Pediatrics has about a dozen medical sub-specialty divisions conducting clinical research at a given time: clinical trials, retrospective analyses, biorepositories, and longitudinal and non-interventional studies of rare diseases, etc. These divisions can be even further sub-specialized down to the investigator portfolio level.

Perhaps understandably then, there is a great deal of variety in the types of sponsors and research in this space. At a given time, about 50% of our projects are likely to be industry-sponsored, 30-35% non-profit sponsored, and 15-20% collaborative (industry and non-profit involvement). We must be intelligent in the way that we manage this because complexity readily travels into the legal, safety, finance, and operations arenas.

At UCLA, the sponsor types and project types dictate specialized contracting unit workflows. To avoid delays in start-up, knowing which office to engage for support in negotiation of a sponsored agreement is essential.

The Office of Contracts and Grants Administration (OCGA) 2 manages all federally-funded research awards as well as research awards funded by non-profit organizations or the state. This office supports the university at large, not only the health sciences.

UCLA also supports clinical research partnerships with private industry. There are two specialized contracting units for these partnerships:

Clinical Trials Contracts and Strategic Relations (CTC&SR) 3 deals in clinical trial research awards for the investigation of medical devices, biologics, and investigational drugs. This office supports the health sciences specifically.

The Technology Development Group 4 supports industry-sponsored clinical research awards that are not clinical trials. Like OCGA, this office supports the university at large, not only the health sciences.

In instances of for-profit and non-profit partnership, the general process guidelines are modified to suit the needs of the project.

Finance and Operations

Gaining approvals from the variety of ancillary medical services necessary to accommodate all protocol requirements can be another barrier to completing start-up. Upon receiving an application and completing a service analysis, each support unit produces its own budget that will be included in the sponsor’s overall project budget.

A non-exhaustive list of these ancillary service units includes the investigational pharmacy, the clinical and translational research center, clinical radiology, clinical pathology, anesthesia, pheresis and stem cell units, nuclear medicine, ophthalmology, a functional assessment lab, highly specialized core laboratories 5 , a medical device formulary, and a gene and cell therapy manufacturing facility. 6

When sponsor clarification is required, it can be challenging for teams to pull together all of the necessary ancillary service agreements in a timely fashion, but it is essential to the financial and operational success of the project.

Putting aside the well-known and valuable role of medical IRBs in clinical research, and considering for a moment a specific aspect of the process as it relates to the whole, what may not be obvious to sponsors, and which may not be true at all academic medical centers, is the role that the IRB plays in holding its approval back until other important safety or scientific approvals are shown to be in place.

At UCLA, a non-exhaustive list of these other approvals includes committees for internal scientific peer review; medical radiation safety, biosafety, and/or a central IRB approval. If our IRB has not issued its local approval, it may very well intend to do so once these other committees provide theirs. If study teams do not make this distinction clear to sponsors or to colleagues within the organization, the issue may be confused and complicate the overall outlook for start-up at the site.

Ultimately, UCLA requires legal, financial, and safety approvals from study teams in order to undertake a sponsored clinical research study. Project specifics often mandate the path that a project takes, and it is the site’s responsibility to guide sponsors along the selected path.

Tools and Techniques for Effective Study Start-up

Since infrastructure and priorities naturally vary from one organization to the next, in most cases the following recommendations are purposefully general to allow for easy adoption and modification to the specific needs of individuals, programs, and organizations.

Project Management

Organizations recognizing value in an independent project management role may find more success in this landscape than those organizations that do not. This is because the many legal, safety, financial, and operational concerns in start-up must be kept on track to meet start-up goals, and they do not cease with site activation. If existing study team members do not have the ability to do project management because they are tending to other essential responsibilities, like coordinating patient visits for active studies, reporting data to sponsors, and maintaining the regulatory body of ongoing studies, etc., then the site might consider appointing a dedicated project manager to provide effort in this space.

Simple Software

UCLA Pediatrics uses a formulated Microsoft Excel spreadsheet to track administrative and scientific tasks required for study start-up. In addition to providing a reliable space to track our process data, we also have the local flexibility to modify and adjust to the real-time environment. We use this approach to track, among other things, the average length of time that it takes to activate a project in our portfolio. Knowing about how long study start-up takes makes it easier to manage expectations and plan for each new project sent down a similar path. We are also able to measure and target slowdowns in any of the major start-up pathways.

Advanced Software

The more rapid flow of information is essential to start-up. UCLA made a strategic decision to leverage its existing and familiar webIRB system as the front end of a multi-program research continuum called ResearchConnect. 7 The webIRB interfaces with the CTMS, which in turn interfaces with the electronic health record. This fundamentally restructured the study activation pathway from the previous disconnected IRB, finance, and contracting reviews into a parallel review model initiated at the point of webIRB submission. Now legal, safety, and financial reviews happen in parallel, and uniform information is disseminated more broadly to stakeholders, aiming to shorten the period between submissions and approvals to the greatest extent possible without sacrificing quality.

Obvious Communication

Whether using telephone, email, or in-person meetings, or using all three, regular communication and periodic status check-ins have an uncanny way of advancing a project toward approval.

The Single Application Method

Committee applications take all shapes: hard copy forms, emails, online applications, etc. It is necessary to prospectively identify all required study approvals and prepare the applications at once. Use a major deadline for a target, perhaps the IRB’s deadline. Submit all required applications on the same day to establish a uniform starting point. This approach lends predictability to the work: someone will not need to remember to get something else in later when other approvals may depend on it. One will most likely have their minor approvals in hand when they need to provide them for major approvals. This approach brings alignment and quiet to an unruly information exchange.

Create a Checkpoint

About a month after submission (or sooner if to needed), plan to meet with project stakeholders to ensure completion of initial tasks and to discuss the final steps to be taken to complete start-up. At UCLA Pediatrics, this meeting has taken the form of a finance committee meeting in which we gather ancillary service approvals with cost estimates and present the budget for PI review. We also take it as an opportunity to remind ourselves that we must push ahead with energy to reach the finish line.

Completion of Start-up

Tying up loose ends is easier said than done. As one nears the end of the start-up period, one should not be ashamed to over communicate the team’s desire to complete the agreement. Involve all necessary parties in a single conversation so that nothing is missed. Keep in mind that we do not do clinical research because start-up is a grand challenge; we do start-up so that we may do clinical research.  

Declaring the goals for study start-up at the onset is the first step toward clinical trial success, but then, execution and tenacious follow-through are key elements of reaching goals. Study teams should actively engage stakeholders within the organization, and the sponsor, to ensure understanding of the study-specific needs and organizational requirements. Study teams should also employ tools and techniques to keep all parties engaged as necessary throughout study start-up so as to reach an agreement as quickly as possible. One success leads to another!

#          #          #

Goals for Study Start-Up

• Meeting sponsor expectations
• Executing on institutional mandates
• Stakeholder understanding of the process
• Identifying and overcoming project complexities

Barriers to Study Start-Up

• Specialization vs. Standardization
• Contracting according to project types and sponsor types
• Specialized ancillary support services and budgeting
• Diffused safety and scientific committee approvals

Tools and Techniques for Effective Study Start-Up

• Program trackers
• Software applications
• Communications
• “Single application” method
• Follow-through

4 thoughts on “Tools and Techniques for Effective Clinical Research Start-up at an Academic Medical Center”

Your article really piqued my curiosity. I had to consider some of your unique ideas in order to think about them a bit. I agree in part with your views. Thank you for interesting content.

it is easy to make a goal in clinical research but hard to execute. there are some unique ideas in this blog. thank you.

hey it looks important. greatly defined meaning of clinical research. thank you for sharing.

Streamlining the study start-up process through effective project management and communication tools is crucial for accelerating clinical research projects. Clear goals, proactive identification of barriers, and the implementation of appropriate techniques can enhance efficiency and collaboration, ultimately leading to successful study execution.

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What's Involved in the Study Startup Stage of a Clinical Trial?

What is the startup stage of a clinical trial.

A clinical trial occurs in three parts: startup, maintenance, and closeout. The startup stage of the clinical trial includes the initial steps to getting the study up and running. This is an important phase of the process since clinical trials that get off to a good start are more likely to succeed. 

Key Steps to the Study Startup Stage

The study startup stage typically involves the first three months of the clinical trial. During this time, there are some critical steps to getting the study started effectively.

1. Building a Budget

Budgeting is one of the first steps to successful clinical trial management. Some factors to consider when developing a budget include:

• The scope of the trial: The trial budget will be affected by how many patients and sites are needed.
• Testing schedule: Your testing schedule and turnaround time should be considered when forming your budget. This includes the time between patient visits and how long it might take for blood testing results to come in to determine if a subject is eligible.
• Shipping: Shipping is one of the major expenses when it comes to a clinical trial. Some things to consider when thinking about shipping include how many sites will be shipping out samples and how many times ACM will be shipping samples to their referral labs.
• Temperature control: Related to shipping cost is temperature control. If samples require temperature control, specialty shipping and storing and additional costs may be necessary.

Read our Blog:  Effective Steps to Clinical Study Management

2. Designing a Protocol

A clinical trial protocol should include key milestones that need to be met, any testing subject inclusion and exclusion criteria, and a schedule of events.

According to ACM Associate Director Regina Harrison, “One of the most important aspects of the protocol is the inclusion and exclusion material, including what milestones patients need to achieve to be included in the trial.” Harrison adds that “Based on this inclusion and exclusion material, we will break down the testing schedule to determine what is needed from us and when.”

Once complete, the protocol must be approved by the Food and Drug Administration (FDA) and reviewed by the appropriate boards.

Read Our Blog: Clinical Trial Design Best Practices

3. Signing a Startup Agreement

After the protocol is signed off, our project managers will work with the client to understand the protocol, the scope of the trial, timelines, and the budget. After this point, the client can either sign a startup agreement with us or complete a work order to detail the cost.

4. Initiating Documentation

Based on the client’s protocol, the project manager will help initiate the documentation process. This includes drafting a Global Laboratory Specifications Document (GLSD) that outlines how ACM will conduct the trial, specifications around the trial, and what tests will be involved. The documentation process also includes creating a lab manual to detail the collection kits, what tests will be collected, and how everything should be packaged and shipped to ACM.

5. Customizing Kits for Sites

During the study startup stage, the major milestone is getting kits on sites to begin collecting samples. This can only occur once all documentation is complete. The project manager will work with the setup team to set up a database based on the GLSD and, depending on the protocol, then begin building the customized kits. The kits are then shipped to each study site so patients can begin enrolling.

Read Our Blog: Key Considerations for Clinical Trial Specimen Collection

How to Mitigate Common Risks to the Clinical Trial Startup Stage

The study startup stage sets the tone for the rest of the clinical trial. Any resets to the timeline during this stage can negatively impact the client’s ability to meet their first patient visit if sites do not have the materials they need to obtain samples.

According to the National Institutes of Health (NIH), around 80% of clinical trials do not meet their initial timelines, resulting in up to $8 million in lost revenue each day.

Here are some ways you can help mitigate this common risk:

1. Be Responsive and Timely about Getting Documents Finalized

Finalizing the GLSD and lab manual is one of the first steps in the clinical trial process and one of the first areas where delays can happen. A delay early on can affect the trial’s ability to meet significant milestones, such as having kits on site. Prioritizing the review of the necessary documents and responding to the project manager promptly can help you avoid this risk.

2. Be Open to Collaboration

Collaboration with the project manager is an integral part of the startup stage. Our project managers will ask questions about the protocol, identify potential roadblocks, and review the timeline and budget. Being open to collaboration and practicing timely communication can improve this process.

3. Have Important Site Information Ready

To keep a trial on track, it’s essential to ship out kits as soon as the database is complete. To do this, ACM requires the correct contact information for the sites as well as the order of priority.

Read Our Blog: How to Plan a Phase 1 Clinical Trial

The Project Manager’s Role During Startup

The project manager plays a vital role in every phase of the clinical trial process. During the startup stage, the project manager’s main goals are to establish regular communication, identify potential risks, finalize all necessary documentation, and get customized kits shipped on time .

At ACM Global Laboratories, our project managers act as an extension of your team. By involving a project manager early in the process, you can establish consistent study management to ensure the success of your trial better. Get started with ACM today.

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A solid foundation for study success

When your future rests on the outcome of a study, you need a dependable platform for an effective trial launch. Premier Research begins with our expert global team, then adds proven processes and innovative technologies to deliver smart study start-up — with no wasted time or money.

Our people are what make the difference when it comes to ensuring every piece falls into place. One dedicated lead oversees every aspect of your global trial, driving timelines, preparing core documents, planning for regulatory reviews — and providing one point of contact to address all your questions.

Study start-up tailored to your study’s specific needs

From identifying the sites to compiling the core clinical regulatory packages, a dedicated study start-up team supports your effective project launch. Our work is guided by consistent processes, consistent oversight, and consistent accountability.

• No mirroring structures required; our subject-matter experts handle each key start-up activity, then unify their output in a comprehensive package
• Clear-cut Standard Operating Procedures (SOPs) ensure constant high quality across deliverables and projects
• Flexible setup reflects your study’s unique priorities

Transparent, real-time access to all start-up activities

Our Study Start-Up application — part of ePremier — automates the collection of all trial-related data, then applies workflow optimization to decrease cycle times and compress timelines. That helps us easily navigate through data to identify the most urgent tasks, keeping even the largest global studies moving smoothly across dozens of sites in multiple countries.

• Task automation streamlines workflows and responsibilities, slashing manual work and duplicated efforts
• Centralized activity and document tracking supports collaboration across teams
• Integrated system applies critical path methodology to help with prioritizing assignments and removing roadblocks to meet deadlines, ensure consistency and simplify follow-up
• Built-in templates reflect our team’s vital in-country regulatory knowledge, simplifying compliance with one click

Part of our Study Start-Up application, PremierPredict™ is a powerful clinical trial enrollment probability simulator that we use to deliver more structured, efficient planning for country and site activation and patient recruitment – not just at the initial stages but throughout the full course of your project.

• Alleviates uncertainty and delivers successful on-time clinical trials
• Delivers more accurate patient recruitment projections more quickly with calculated mapping for each country, site, and patient
• Enhances decision-making with visualizations, detailed numbers, and project milestones
• Ensures your development program stays on track with the ability to remodel enrollment projections as needed throughout the study

Premier Study Start-Up

Industry-wide, spreadsheets have long been the go-to method for tracking clinical trial start-up. Premier Research developed ePremier to create a paperless, electronic data process, start to finish.

PREMIER PERSPECTIVE

Ensuring compliance with gdpr.

At the beginning of a study, there are a number of steps sponsors and CROs must take to ensure compliance with the EU’s General Data Protection Regulation. In this blog post, we focus on four GDPR articles that are relevant to study start-up.

Related Services

Study start-up is part of a wide range of service offerings that include regulatory consulting, project management, and data management. Follow the links below to learn more about how clients gain from our specialized expertise.

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Results demonstrated prolonged progression free survival of two patients in Acclaim-1 study and partial remission from maintenance therapy in Acclaim-3 study.

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Phase III Vivacity-MG3 Trial Demonstrates Superiority of Nipocalimab Over Placebo in Treating Patients with Generalized Myasthenia Gravis

Reportedly, data from the Vivacity-MG3 trial marks the first time an FcRn blocker demonstrated superiority over placebo in treated generalized myasthenia gravis (gMG).

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Study Start-Up

The clinical study start-up process has been improved and automated. Clinical Research Connect is a new workflow application that was developed to support clinical research study start-up activities.  Clinical research staff will use the Clinical Research Connect workflow application to initiate and complete the study start-up process for all studies that require IRB-HSR review. The Clinical Research Connect workflow application assumes that you have a protocol and that funding has been secured.  At some point early in the process you will need to complete questions in IRB Protocol Builder as per the usual process.

The workflow system’s functionality includes: single data entry for a number of common data points across various systems, electronic submission to multiple functional areas, smart and proactive validations, automated notifications, electronic signatures, auto-generation of documents, and reporting.  The new automated process will allow everyone involved in the study start-up process to realize increased visibility.

If you have any questions about the process in the system, contact Clinical Trials Office at 434-924-8570.

Grant Pricing Request Application

The Grant Pricing Request Application allows study teams to access procedure cost information and create cart(s) with all the required procedures for the study. The research charge master (research rates) is updated by MC Finance and UPG at least annually and uploaded by SOM Clinical Trials Office (SOM CTO) to the Grant Pricing Request Application. Research rates for clinical research studies will be based upon the version of the research charge master that is in effect on the date the study is entered into Clinical Research Connect.  MC research prices will be guaranteed for the duration of the study. UPG does not guarantee their pricing.

If you have questions about the application, contact the SOM Clinical Trials Office at 434-924-8570.

Getting Your Study Started

The study start-up section is divided into 3 sections – compliance, budgeting and contracting.  Please note that the tasks in these 3 sections can be completed concurrently, keeping in mind, however, that some steps are dependent upon the completion of others (for example, you must have the approval of all other applicable review committees prior to obtaining IRB approval, and you must have IRB approval of your protocol before the study contract/agreement can be executed).

Once you have responded to all questions, you will have the opportunity to print or email your results to you inbox for reference.  To your left, you may also click through the menu, to see these topics on individual pages.

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Study Start-Up

For research, source documents are defined as the first place information is recorded. If you plan to collect information that you normally would not, create forms specific to your protocol for capturing this. If you forget to capture protocol defined measures, you have deviated from your protocol which may be reportable, and you may not be able to prove your endpoints if you leave missing data.

Source documents should limit protected health information (PHI) as much as possible, but research staff should easily be able to match the source to the correct study patient for safety reasons. Case report forms should be de-identified (not contain any PHI). Consider using REDCap™ and a source or CRF. See the sample source document tools in resources.

Hospital policy requires that essential regulatory documents be maintained for all studies. See UH Research SOP SS 301: Maintenance of Research Regulatory Documents  for help in organizing a regulatory binder and read GCP E6 R2 (Section 8) for details and purpose of the Essential Regulatory Documents.

Consider attending Education: Regulatory Binder and Essential Regulatory Documents and contact [email protected] for help.

Each time you start a new study, you should meet with your study team to have a protocol training team meeting. Require the attendance of everyone doing work on your study.

If you cannot come together in person then a web or teleconference is a good alternative. This is a great time for the primary investigator (PI) to delegate tasks and train everyone on what their responsibilities will be in a meaningful and transparent way.

Be sure to document this training for each staff’s training record and make available in the event of an audit. Also, be sure to have a plan in place for PI oversight of the entire study and for the study tasks that have been delegated to the study staff. Remember, the PI can delegate tasks but is ultimately responsible for the conduct of the study. All tasks must be delegated to a person who is qualified to do the task (clinical or non-clinical), see UH Research SOP GA 104: Scope of Practice .

During the team meeting and protocol training is a good time to complete the Study Staff Delegation log if you have not already.

As you add new research personnel or remove old, modify the log, the Institutional Review Board submission and training records accordingly. Also be sure that CITI and CREC certifications, CVs and licenses remain up-to-date and are available.

Some notes:

• Train all investigators and staff on the protocol prior to any study activities and retrain with changes to the study.
• All tasks that the PI delegates must be listed on the delegation log.
• GA-104: Scope of Practice
• GA-105: Investigator Responsibility for Study Team Training and Documentation
• SS-303: Site Initiation Visit

To help ensure the success of your research project, the Clinical Research Center offers complimentary consultations to help you reach your goals. These consultations ideally occur prior to IRB submission but can happen at any point in the progression of your research study.

Once a fully executed agreement is in place, the Pre-Award Grants & Contracts Pre-Award team notifies Grants & Contracts, Post-Award Grants Accounting, the department administrator and PI that a fully executed agreement has been received. The department administrator or PI then complete two forms:

• Chart of Accounts

Both forms should be emailed to [email protected] or to the GA assigned to your department. Once received, Post Award requests a Project number from finance, adds new sponsors to the system, and sets up your account.

Finally, Grants Accounting sends an email with the Notice of Award containing necessary account information to the department administrator and PI. The assigned PTAEO number will be used to make necessary charges to the award.

Once your study has been IRB-approved and a grant account has been set up for the financial management of your study, you are ready to enroll patients. If your study involves clinical patient care, a member of your study team will be responsible for adding that patient to your study coverage analysis and updating that coverage analysis each time research-related care is provided to that participant. Contact your Research Finance Specialist for more information. The following policies and Clinical Research SOPs will help:

• UH Policy & Procedure R-2 – Research Patient Billing
• SOP SS-302: UHLSF Outpatient Research Patient Charge Billing Process
• SOP SS-304: Investigational Drug Billing
• SOP SS-305: Investigational Device Billing
• SOP SS-314: Velos eResearch – Access and Data Entry Requirements

Solutions > Clinical Development > Clinical Operations > Study Start-Up

The key to swift clinical trial start-up is a combination of efficient regulatory submission and approval, as well as expedited investigator site activation. Reducing the cycle time of study start-up requires strong therapeutic expertise, a focus on working with sites proactively during start-up, a profound understanding of dynamic global and local guidelines, and a broad geographic network of regulatory personnel. Drawing on extensive clinical research expertise and site knowledge, our teams work in tandem with yours to efficiently manage every aspect of study start-up.

Bring your research to life with ClinChoice’s comprehensive package, encompassing regulatory expertise and team capabilities to ensure the overall success of your study.

Robust regulatory expertise spanning local laws and global guidelines

Dedicated project team members to streamline and optimize every facet of study start-up

Project management  grounded in quality, risk mitigation, cost-effectiveness, and precise timing

Proactive and detailed communication and planning with our clients

Start-up differs in every study. Our services apply across diverse sectors, each with unique considerations.

Applying regulatory and clinical expertise, as well as our global reach and established site network, to optimize start-up times and initial planning phases.

Leveraging deep knowledge of global regulation and established site networks.

Setting the foundation for a well-conducted study considering innovative decentralized designs.

Initiating and executing studies in diverse markets, including cosmeceuticals and nutraceuticals.

Clinical Trials Transformation Initiative

• Study Start-Up

Home - Our Work - Investigators and Sites - Study Start-Up

Study start-up (SSU) for randomized controlled trials is usually a long and costly process that can cause significant delays.  

Addressing this challenge, CTTI conducted work to identify specific metrics and benchmarks related to SSU, recommending greater standardization  within the clinical trials ecosystem. More recently, it also conducted research and  released a  report showing that budgets and contracts are significant contributors to delays, laying the groundwork for future industry work on remodeling the SSU process.  

Recommendation Summary

Recommendations, related items.

• Study Start-Up Timelines: Identifying Challenges & Opportunities for Change
• Cycle Time Metrics for Multisite Clinical Trials in the United States
• Expert Meeting on Site Metrics for Study Start-Up
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• CTTI Report Finds Contracting and Budgeting are Significant Pain Points for Study Start-Up It’s no secret that the entire clinical trials ecosystem is affected by painfully slow study start-up timelines. CTTI recently sought to investigate the factors that influence this crucial problem. After ...

Prolonging the time from protocol finalization to participant enrollment can have detrimental effects on the overall success of a given trial; this is especially true in large, multisite trials. While reducing the time required for study start-up (SSU) activities will lead to considerable benefits to trial conduct and drug development overall, the lack of standardized, industry-wide metrics poses a challenge to implementing wide-reaching change. At the time of this project’s initiation, little information was available on the variability of site performance and the factors that contributed the most to delaying SSU.

Site Metrics for Study Start-Up (2010-2013)

Identify and quantify components of SSU activities to enhance SSU and trial enrollment.

Resolution of the issues identified by CTTI can inform an enterprise-wide effort to define standard, universal SSU metrics/definitions.

Three workstreams with distinct roles were defined to gather evidence:

• Developed a preliminary list of proposed data elements from which to generate standard metrics for SSU activities
• Tested the workability of this list by retrospectively collecting these data elements from multiple organizations conducting clinical trials and by calculating metrics from these data elements
• Expert meeting

During the early phase of this project, CTTI developed proposed definitions for SSU benchmarks and obtained data from research coordinating entities. Cycle time for different metrics (e.g., site cycle, site-to-IRB cycle, site-to-contract cycle, site-to-patient cycle, IRB cycle variables, post-contract-to-patient cycle) was, in part, dependent upon organization type. Of the seven-time cycles measured, six were significantly associated with IRB type. Factors that were significantly associated with reduced cycle times included the use of single IRBs .

A retrospective data collection effort and discussion during the expert meeting revealed substantial inconsistencies in the collection and definition of SSU data that was tracked by different organizations and even within the same organization. In addition, there was often decentralization of these data and storage in multiple databases within organizations. The decentralization of data and lack of consistent, standard SSU definitions pose a significant challenge to gathering quality data on SSU metrics and inciting change in this area. Additionally, data governance policies of many organizations may also impede standardized definitions.

Findings of CTTI’s evidence-gathering activities were  published in January 2013, detailing the wide variation in how data is collected, defined, stored, and governed across organizations and how this will impact attempts at a meaningful prospective collection of data. Future development of standard measures of SSU efficiency will be critical to analyzing and improving study initiation processes at U.S. research sites; however, this may also require large-scale changes to infrastructure.

Organization affiliations are listed as active affiliations during the project.

Global Clinical Research: The Process from Start to Finish

Play an active role in improving patient care worldwide.

At a Glance

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Students may register up to 7 days after the course start.

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Gain an overview of principles and practices in clinical research from a global perspective.

The University of Chicago’s eight-week Global Clinical Research course focuses on the clinical trial process and phases— from study start-up to trial closeout. Upon completing the course, students will be equipped to apply their new knowledge and skills to thrive in a controlled and highly regulated work environment.

Designed For

Designed for healthcare, medical, and research professionals interested in starting or advancing their clinical research careers. A background in the life sciences is advisable.

Learning Objectives to Become a Clinical Trial Expert

The clinical research trial area is growing rapidly. Clinical trials are essential to making advances in diagnosing, treating, and preventing diseases and medical conditions. Demand for professionals equipped with the right clinical trial-related skills is soaring. Learn the processes and global regulatory procedures necessary to bring medical devices, treatments, and vaccines to market.

After completing the course, you will be able to:

• Identify key terms and concepts of clinical research.
• Describe core ethical principles that ensure that the rights and safety of human subjects are protected.
• Examine the core principles and practices of clinical trials from a global perspective.
• Define the ethical principles that guide the informed consent document and process.
• Determine key factors that trigger a protocol amendment.
• Earn a credential certifying completion from the University of Chicago and become part of the UChicago network.

Demand for Experienced Clinical Trial Professionals is High

Register today and unite your professional practice with our distinctive blend of academic rigor and real-world application.

Clinical Research Curriculum

You will learn to:.

• Navigate the clinical trial process from study start-up to trial closeout.
• Explain the critical historical events that led to the globalized standardization of research conducted worldwide.
• Describe core ethical principles of clinical research to ensure that the rights and safety of human subjects are protected.
• Define the purpose of a clinical trial and develop standards for data collection and data quality to ensure data integrity.
• Employ key terms, concepts, and acronyms associated with clinical research to effectively communicate with key industry stakeholders.

Online Format Features

• Self-paced interactive learning modules with a variety of engaging learning activities, assignments, and resources.
• Live sessions that bring you, your peers, and your instructor together to learn collaboratively about the current state of the field, engage with real-world problems, and explore authentic solutions.
• Continuous support from your instructional assistant, who will accompany you on your journey through the content, answer your questions, and provide feedback on your work.

Weekly Course Schedule

Explore clinical research and the current landscape of the industry, the ethical framework that guides the conduct of clinical research, the historical events and importance of Good Clinical Practice (GCP) in clinical research conducted around the world, how we protect the rights and safety of human subjects, and the need for globalized standards in clinical research. 

Learn about the overall goals and types of clinical trials, the different phases of a clinical trial (Phase I, II, III, and IV), and ethical considerations in the design and execution of international clinical trials.

Learn to assess the characteristics of a good research question, examine the essential elements and significance of a clinical trial protocol, and determine key factors that trigger a protocol amendment.

Explore the ethical principles that guide the informed consent document and process, essential elements that should be included in the informed consent discussion and written informed consent, and challenges in the informed consent process.

Learn about the roles and responsibilities of clinical trial investigators, sponsors, and Contract Research Organizations (CROs). Examine key steps in planning and activating a clinical trial and the role of monitoring to ensure that a trial complies with international regulations, standards, and guidelines.

Examine the roles and responsibilities of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) concerning human subject research. Discover the role of Data Safety Monitoring Boards (DSMBs) and the regulations that guide them. Explore a real-world example of DSMB involvement in clinical trial oversight.

Learn about the importance of data collection and setting data quality standards for clinical research, developing strategies to ensure high-quality data, and analyzing critical data points and risk indicators.

Visualize the overall clinical trial timeline from start to finish and examine the importance of study closeout and results reporting.

Earn a Credential in Global Clinical Research

After successful completion of this course, participants will receive credentials certified by the University of Chicago including a digital badge to recognize their achievement.

Enroll Today   Learn More

Meet Your Instructor

Our highly trained instructors are courageous thinkers and passionate leaders who leverage years of industry expertise and up-to-date knowledge of terminology, tools, and trends to deliver an unparalleled learning experience. Through their rigorous discourse, cross-disciplinary collaboration, and field-shaping contributions, they create practical solutions and pioneering innovations that enrich our world.

Lauren Wall, MSc

Senior Director, Cancer Clinical Trials Support Office at the University of Chicago Comprehensive...

Lauren Wall is the senior director of the Cancer Clinical Research Support Office within the Comprehensive Cancer Center at the University of Chicago Biological Sciences. Wall has over seventeen years of experience in Hematology/Oncology clinical research operations spanning industry and academic...

Career Outlook

The global clinical trials market—valued at 46.8 billion dollars— is expected to grow at a CAGR of 5.1% from 2022 to 2030. In this thriving field, key drivers like the globalization of clinical trials and new, personalized treatments continue to impact market growth while demand for skilled professionals widens the job market.

The  average base pay  for a clinical trial associate in the United States.

The number of clinical studies registered globally as of April 2024.

The expected value of the global clinical trials market  in 2028.

Potential Job Titles for Clinical Research Professionals

• Clinical Operations Director
• Clinical Research Associate
• Clinical Research Coordinator
• Clinical Research Manager
• Clinical Trial Assistant
• Clinical Trial Associate
• Data Manager
• Drug Safety Associate
• Research Nurse

Of Interest

Non-credit certificate program in clinical trials management and regulatory compliance.

Accelerate your career in the field of clinical research with hands-on training in every step of the...

• Accelerate Your Career in Clinical Trials

From Healthcare Technician to Clinical Researcher

A Global Perspective on the Pharmaceutical Industry

• Non-Credit Certificate Program in Clinical Trials Management and...
• New Frontier in Patient Recruitment

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Study Start Up

In Study Start Up (SSU) we support the start-up process and manage the critical path to site activation.

SSU is one of the most complex and heavily regulated parts of any clinical trial or program launch. This period involves a significant number of stakeholders at start-up sites, regulatory agencies, vendors as well as the customer.

Working efficiently in SSU, we help reduce the time it takes for patients to start their clinical trial journeys and help bring lifesaving treatments to those that need them.

• Functional Service Provider (FSP)    
• Full Service    

Functional Service Provider (FSP)

An FSP relationship is a partnership between a CRO and a Sponsor. Every partnership is unique with each one tailored to achieve our customer’s visions and goals. This allows us to grow and evolve with our customers as their portfolio needs evolve.

For Syneos Health it means that colleagues who like structure and predictability, and who truly enjoy relationship building in the work environment, tend to thrive in FSP environments.

Sponsors look to Syneos Health for technical expertise. They expect our colleagues to be an extension of their team and to bring new ideas; demonstrate expertise in technology and processes; escalate recommendations for improvements and take opportunities to innovate. In other words, Syneos Health has a voice.

Full Service

Full Service is a prominent service model among CROs and critical to Syneos Health.

The Full Service environment is dynamic with multiple Sponsors and project assignments. Our Syneos Health colleagues gain broad exposure to therapeutic areas and multiple Sponsors’ processes, roles, technology, financial experience, end-to-end project work and business development opportunities.

Timelines can be fast paced and colleagues in a Full-Service model tend to thrive on variety and are not averse to change, truncated timelines and a degree of unpredictability.

Date Posted

Site activation specialist i, site activation specialist ii - sponsor dedicated full service - bulgaria, site contracts specialist ii, site contracts specialist, fsp korea, site activation specialist ii, ssu & regulatory specialist, fsp korea, site activation specialist, single sponsor (nederlandstalig), site activation partner - sponsor dedicated (fsp) - homebased, sr site activation specialist - submissions specialist - bulgaria home based, site contracts specialist ii o senior - homebased in spain or serbia - must be fluent in spanish, sr site contracts lead, recruteur de patients - recherche clinique (résidence dans la province de québec requise), inside syneos health.

Discover Your Future with Syneos Health

Corporate careers, global project management careers, clinical development services careers, sites & patients careers.

Syneos Health® is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.

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Phone: 919 876 9300 Fax: 919 876 9360 Toll-Free: 866 462 7373

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com One of our staff members will work with you to provide alternate means to submit your application.

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Study Start-Up & Site Intelligence

Helping you accelerate timelines and increase efficiencies.

Clinical study startup, one of the key cost drivers in your program, requires strong management of critical, time-sensitive deliverables. Data-driven decision-making in study site selection, strategic submission planning and delivery, collection of required documents for site activation, and investigator contract negotiations are fundamental to expediting your project and meeting your recruitment timeline.  

To accelerate clinical trial study startup, our Study Start-Up and Site Intelligence solution focuses on site engagement to reduce study startup cycle times and increase confidence in your study site activation planning and recruitment strategy.  

Clinical Site Intelligence

The strategy of investigator site selection to achieve timely project delivery.

Assessing whether a potential site is capable of navigating the complexities of the clinical trial and meeting the study’s objectives, whilst maintaining compliance is crucial to study success.  

Allucent’s strategy not only relies on in-depth data driven feasibility but also on our comprehensive Site Engagement process.    

Allucent excels in conducting comprehensive strategic feasibility assessments for clinical studies across all phases of development. Building a customized operational delivery plan begins with a holistic evaluation of each sponsor’s unique study design and targeted patient population, followed by an in-depth multifactorial assessment of the epidemiological and competitive trial landscapes, historical recruitment performance, therapeutic expertise, standard of care, and recent operational performance.   

Our team then works closely with our Clinical Operations, Medical, Patient Engagement, and Study Start-Up (SSU) teams to collectively share and refine our recommended country/site strategy, to ensure it is in line with our collective expertise as well as the sponsor’s corporate objectives.  

By partnering and engaging with sites, we can secure early project feedback from Principal Investigators/Sites to validate study assumptions, mitigate study challenges and maximize study delivery including patient accruals, timelines, and data quality.  

Clinical Study Start-up

Prevent unnecessary delays and accelerate study start-up

Prevent unnecessary delays and accelerate study start-up  

Delays in clinical trials are costly. Reducing the time to start up a study can significantly decrease overall expenses.  

Start-up activities can be complex and unpredictable leading to frequent delays. At Allucent, we are committed to help you navigate these complexities by providing you with a detailed study specific start-up planning, describing all steps required for site identification and selection, submissions preparation, site contract and budget negotiations for green light process.  

Upon award, our Study Start-Up Lead will validate this planning with you and identify strategic solutions to accelerate study start-up and site activation. Led by the Study Start-Up functional leads (including Regulatory leads and Site Contract Leads), our dedicated team of country experts execute this strategy while leveraging our internal intelligence data platform.   This data platform includes country specific regulatory requirements as well as site intelligence acquired through previous experience with sites and via close collaboration with our Site Engagement Team.  

In collaboration with the Patient Engagement teams, we maintain high engagement with sites throughout the study start-up period to help them prepare for an enhanced patient recruitment experience.  

European Union Clinical Trial Regulations

Difficulties in navigating the eu ctr.

Understanding when EU CTR applies and navigating through the system and understanding all its functionalities can require significant time and training.  

The European Union Clinical Trials Regulation (EU CTR) is legally binding to all affected countries in EU/EEA and applies to clinical trials conducted on humans and involving an investigational medicinal product (including Advance Therapy Medicinal Product).   

It requires communicating and exchanging clinical trial data with regulatory authorities and Ethics Committees via the Clinical Trial Information System (CTIS) which consists of two restricted and secured workspaces: one for authorities and one for sponsor/CROs acting on a sponsor’s behalf including an open access for patients, healthcare professionals and members of the public.  

As an early adopter of EU CTR, Allucent has extensive experience in navigating the system to manage both clinical trials applications and transition of clinical trials while navigating country specific nuances to drive an efficient approval process.  

We manage redaction of submission documents for compliance with Transparency rules under EU CTR and also offer operational consultancy, and support with registrations of substance, product, sites, sponsor and vendors.

Other Areas of Expertise

Clinical strategy, patient recruitment & retention, therapeutic expertise, clinical development, partner with the a-team.

Let us know how we can help you bring new therapies to light. Get in touch to get started.

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News & Highlights

Topics: Clinical & Translational Research , Five Questions

How to Accelerate Clinical Research

Five questions with michelle beck and yemi talabi-oates on making connections..

At Brigham and Women’s Hospital (BWH), oncologists who’ve been doing gene therapy trials for a decade are teaming up with researchers in other fields to apply their knowledge to the new wave of non-oncology cell and gene therapy studies and avoid recreating the wheel.

And at Beth Israel Deaconess Medical Center (BIDMC), one researcher’s challenges enrolling Black patients for a diet intervention study led to the development of a satellite center at a community-based clinic, which other researchers are exploring for their own studies.

These are among the ways Harvard Catalyst’s Connector sites facilitate and accelerate clinical/translational research across the hospitals affiliated with Harvard Medical School (HMS). Connector links investigators to the medical centers’ sprawling clinical research enterprises and troubleshoots research bottlenecks. (Boston Children’s Hospital and Mass General Hospital also have Connector sites.)

Need a research problem solved?

The premise behind Connector is that clinical research can be challenging, especially in complex academic healthcare environments. Individual scientists can’t do it alone. Connector sites help researchers get science done right–hopefully the first time–while maintaining the highest standards for patient protection, regulatory compliance, and quality.

Connector draws upon the collective expertise of HMS-affiliated institutions to guide studies through the lifecycle of science. For investigators struggling to recruit or wrestling with logistics, the programs offer a kind of life-raft of resources and support, big or small.

As the administrative directors of Connector sites at BIDMC and BWH, respectively, Michelle Beck and Yemi Talabi-Oates are like the Ghostbusters of translational research: They are “who you gonna call” when you’ve got a research problem to solve.

We caught up with them both in one Zoom to find out what they wish investigators knew about Connector.

What’s your cocktail-party summary of what Connector is?

MB: A cocktail-party summary is hard because Connector does a bit of everything, depending on what the investigator wants. Connector sites are really good at figuring out how to set studies up. Our special sauce, so to speak, is the experience in knowing how to make things work.

“Connector sites are really good at figuring out how to set studies up. Our special sauce, so to speak, is the experience in knowing how to make things work.”

At BIDMC, Connector encompasses our Clinical Research Center, a full-service operation providing research coordination and personnel for the lifecycle of a study, including recruitment. We provide laboratory, dietary, specialized nursing–because research nursing is a little different than clinical care nursing–and all affiliated services for inpatients and outpatients in our own research space as well as in other locations.

We help research teams get the tools and resources they need in other parts of BIDMC or across the network of HMS-affiliated hospitals. We might refer them elsewhere or integrate their research into our portfolio.

YTO: Brigham’s version of the Connector is the Center for Clinical Investigation (CCI). We call ourselves the home of clinical research. We are the first stop if an investigator needs help or wants to learn how to implement clinical and translational research studies.

Investigators can use any or all of our resources, from something small to running the whole study. We can connect them with potential collaborators or just find somebody to read an EKG, if that’s what’s needed.

We have clinical space dedicated to research so we can accommodate patient visits. But just as importantly, investigators have access to vital services that are not patient-facing, such as data management, research coordination, and biostatistics support.

What do you wish investigators knew about Connector?

MB: People sometimes think that Connector is the CRC. While it is at some level, it’s also much more. Our strength lies in the collective experience of the many people who have already figured out how to design and conduct high-quality studies, who understand the steps for getting from point A to point B.

Our program director regularly meets with investigators to provide feedback on their grant applications, offer advice on how to find funding, or connect them with mentors.

All of the Connector sites have a role called a navigator. BIDMC navigators are experts in regulatory and operations. Depending on when they’re brought in, they can point investigators to resources or work through specific aspects of their study that might be challenging.

YTO: What I find with investigators is they don’t know what they don’t know. They may come to us with one question and not realize how many other things need to be considered before we can address that one question. Having that dialogue as early in the process as possible will help the investigator in the end.

Connector lets investigators tap the experience of a diverse clinical research team, whether it’s the nurses on the floor or a physician-investigator who’s done this before. It’s about knowing your patient population and what works with recruiting, right down to which time of day is easier for patients. It’s helping avoid the pitfalls that may come with being a newbie to research.

“Connector lets investigators tap the experience of a diverse clinical research team, whether it’s the nurses on the floor or a physician-investigator who’s done this before. It’s helping avoid the pitfalls that may come with being a newbie to research.”

One of the things I often say to early-career investigators or those testing a really novel idea is if you’re going to fail, fail fast. It’s okay to fail because you can use what you learn to make the next study better.

Give us an example of something you’re engaged in right now that illustrates how the Connector sites work.

YTO: One of our big pushes right now is to help investigators in the non-oncology space who are interested in conducting cell and gene therapy studies. We don’t want to recreate the wheel, so we’re connecting them to oncology physicians who have been doing these studies for a while. We’re bringing together players who aren’t otherwise talking to one another to figure out how current systems might be adapted for studies outside of oncology.

MB: We have a general medicine investigator who is running a diet intervention study for hypertension, focusing on enrolling Black Boston residents in areas with ‘food deserts’ –areas with grocery store scarcity. This investigator met with our Connector team early in his grant planning process. His studies are now funded, and he’s running them through our main Clinical Research Center at the Boston campus. But he is having a really hard time meeting his recruitment goals, so we are working with him to set up research support at our Bowdoin Street clinic.

Because of that collaboration, the clinic is being developed as a CRC satellite with a focus on community-engaged research that allows the local community to provide input on the studies conducted there. We are now working with other clinical groups to expand research at the site.

So by addressing a recruitment problem one investigator was having, we’re establishing a resource that other investigators can access to bring research to our community and potentially improve participant diversity in their studies.

Connector’s goal is to accelerate translational science, in line with the mission of Harvard Catalyst and other clinical and translational science programs funded by the National Center for Clinical and Translational Science (NCATS). From your perspective, is clinical research efficient enough?

MB: I think sometimes we have unrealistic expectations about efficiency. I honestly believe that we make things very efficient in our programs and within our institutions, but I don’t think clinical research itself is efficient, through no fault of our own.

It’s really difficult to run a study, especially if you think about the whole lifecycle. For an industry-initiated clinical trial for example, a sponsor wants you to have a budget, contract, IRB approval, and be ready to enroll your first patient within 60 days of being selected as a site, which is crazy. It’s not impossible but it’s highly unlikely, with so many steps and the complexity of various studies.

If you move too fast, you risk making mistakes. If you don’t think carefully about what’s involved in a study from a participant’s perspective, for example, you might meet your recruitment goals right away but have 60% who don’t meet inclusion/exclusion criteria at screening and 20% who didn’t realize they’d have to come in every day for the next six weeks. Those kinds of circumstances can be largely avoided with the right planning.

YTO: We definitely take some time on the front end to get all the information and tweak things where necessary to make sure the patient’s experience and the study team’s experience is positive and efficient. We want to make sure it’s done right, and that might take a little longer.

In the end I’d rather be confident that patients are safe and the data is accurate because we thought these things through up-front. That’s the time to do it, not when the patient shows up for the visit or the investigator sits down to write that paper with flawed data.

How does Connector affect the experience of patients involved in clinical research and why does that matter?

MB: Using a Clinical Research Center is hugely beneficial from the participant perspective. We had a study many years ago in which two people came in every month for seven years for the same study. They got to know each other, and they knew all our staff; they would even bake banana bread for the research center staff. I think if patients get to know the research center, that’s another mechanism for patient retention, particularly for longitudinal studies.

YTO: Agreed. Our nurses and clinical staff on the floor definitely make connections with the research participants, and they often learn something that could be valuable to the study team. Having that connection is key.

It’s not just the study team; it’s every member of the staff. It’s the person who smiles when they walk in the door, or the one who knows about their child or their cat and asks about it. That matters when you want a patient to come back again and again into the next month or year.

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Clinical Research Medical Advisor

About the role.

As a CRMA your responsibilities include, but are not limited to: •Closely collaborates with Study & Site Operations (SSO) to ensure fast clinical trial start up,recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plans. Co own start up phase and the recruitment plan for the development clinical trials with the local SSO organization. •Provide clinical development and indication expertise and drives, together with the local SSO, the execution of clinical trials with high quality and within planned timelines; provide indication and protocol training's to investigational sites as well as SS O colleagues. •Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed back, etc.) and analysis of the competitive environment. •Cooperates with local functions such as e.g. Medical Affairs, Patient access to identify and involve qualified investigators with recruitment potential and relevant key experts for clinical development in order to exploit the value of the assigned project( s) in the context of the investigational product(s). •Review and resolution of local medical issues / questions if necessary, support the discussion of issues to global teams. Requirements: •Scientific degree ideally MD •experience in the pharmaceutical industry with at least 3 years’ experience in clinical development or trial monitoring across different indications / therapeutic areas. •Fluent English •Ability to manage a study from the medical / clinical perspective, and a demonstrated capability to problem solve and mediate complex clinical / medical / operational issues. •Demonstrate an understanding of regulatory requirements and policies, procedures, and guidelines pertaining to clinical trials. •Track record of delivering complex global clinical projects in quality and time. •Excellent communication and interpersonal skills, with ability to build rapport and trust with diverse stakeholders. •This position will require local and international travels; up to 30% of working time Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reac h our ambitions. Be a part of this mission and join us! Learn more here:

https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network :

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkhttps://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Clinical Research Associate 2

• Location: Argentina
• Categories Clinical Monitoring
• __vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions
• __vacancyopjusttionswidget.opt-Remote Working __ Remote

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About the role.

As a Study Start-Up CRA (SSU CRA) will be responsible  of creating and endorsing submission packages related to the country or site, following ICH, GCP, and all relevant regulations, laws, guidelines, and ethical standards, within specific deadlines and quality standards, if applicable (depending on the country). Responsible for examining and endorsing critical documents at the site level for site activation, in accordance with regulatory/sponsor requirements, within specific deadlines and quality standards.

Main activities

• Perform feasibility, site identification, and other study start up activities, as assigned.

• Prepare, review and submit submissions to ethics and regulatory and other relevant authorities or agencies (if required) in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

• Develop and finalize Country Specific ICFs (if applicable for country).

• Prepare and finalize Country Specific xml files (if applicable for region).

• Perform independent quality review of submission packages. 

• Collect and maintain (or have oversight if applicable) current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant ICON or client information system.

• Responsible for the coordination of translations for documents required for submission (if applicable for country).

• Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system in collaboration with the CTAs (if applicable for country).

• Route incoming correspondence, internal documentation, etc., as appropriate.

• Responsible for the timely follow-up for queries made by EC and CA (if applicable for country).

• Responsible for the review and approval of critical documents required for site activation and IP Release, as appropriate.

• Attend study team meetings as required.

• Be familiar with ICH GCP, relevant country regulations/guidelines and ICON/client SOPs.

• Assist and provide support to the RCTM to maximize submission effectiveness, minimize timelines and ensure sponsor satisfaction.

• Undertake other reasonably related duties as may be assigned from time to time

Requisitions

• Bachelor’s degree in a health, life sciences or medical fields. • Experience with study start-up activities and on-site monitoring experience.  • Availability to travel when required. • Fluent English and Spanish (read, write and speak)

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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