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CLINICAL TRIAL MANAGEMENT

Clinical Research Associate (CRA) Training Academy

Linical has developed a specialized CRA Training Academy where talented research professionals cultivate their clinical monitoring skills through a unique, extensive training program covering all facets of clinical research monitoring and site management. We also offer a bridging program for those with clinical research experience, for example, Study Coordinators and Clinical Trial Associates, who desire to enhance their understanding and skills.

Linical’s CRA Training Academy enables skilled professionals to become high performing Clinical Research Associates with superior monitoring skills across many therapeutic areas.

Process

Best-In-Class Clinical Monitoring Training for CRAs

Linical’s CRA Training Academy graduates are highly sought after by our clients, due to their exceptional clinical monitoring skills and attention to detail at site visits. Our CRA Training curriculum is a deep dive into all key facets of the clinical monitoring role.
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Identifying Top Candidates
Candidates undergo an intensive seven-week training course facilitated by Linical’s Senior Director of Clinical Monitoring. CRA Academy candidates are vetted for their therapeutic knowledge and site experience is strongly preferred.
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Hands-On Training
As part of their training, candidates are required to conduct a mock Site Qualification Visit and a mock Site Initiation Visit and observe each type of monitoring visit (including site qualification, initiation, interim monitoring and close-out visits.)
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Graduation
Course content is presented virtually, and self-study assignments allow for independent completion. Candidates are also responsible for independent textbook reading assignments and completion of GCP findings exercises through an industry-leading training platform. Graduation from the Academy is dependent upon a passing score of 80% on the mid-course and final assessment.

Purpose-Built CRA Training

Our CRA Training Academy graduates are equipped with the knowledge and job training needed to expertly manage clinical sites and conduct monitoring visits, all while ensuring study conduct is in accordance with ICH/GCP Guidelines and applicable regulations. Our mission is to drive exceptional execution in clinical research by providing high quality monitoring and site management skills, while protecting the rights and welfare of the patients.

CRA Training Curriculum

Linical’s CRA Training Academy covers all key facets of clinical monitoring including:

 

CRA Bridging Course Outline
CRA Overview: Characteristics of a CRA?
The Back Story: Project activities prior to CRA joining a project
ICH-GCP Considerations from the Monitoring perspective
Protocols and Amendments
Project Assignment
Monitoring Plans
Trial Master File(TMF) and Investigator Site File(ISF)
Identifying and Selecting Investigators (Site Qualification Visits)
Project Communications (Emails, Letters, Visit Reports, Escalations)
Initiating Investigator Sites (Site Initiation Visits)
Monitoring a Clinical Research Study (Interim Monitoring Visits)
AE/SAEs
Protocol Deviations
Site Management, managing action items, root cause analysis, problem solving
Database Lock
Closing a Site (Close-Out Visits)

Linical’s Other Clinical Research Training Academies

Clinical Research Site Training Academy

Linical’s Site Training Academy is a comprehensive and personalized program designed to educate physicians and their staff new to research. This program provides the tools and support necessary for trainees to become knowledgeable, confident, and successful clinical researchers.

Clinical Trial Manager (CTM) Training Academy

Linical’s CTM Training Academy gives participants the skills needed to advance their clinical research career as a Clinical Trial Manager, capable of expertly managing many types of clinical trials.
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OUR BENEFITS

Why Linical?

The clinical development journey can be daunting and often leads to failure. With so much riding on your compound, you deserve the best chance at achieving your goals and positively impacting patients across the globe.

As a global, award-winning CRO, we can provide the strategy and support you need to position your clinical trial for success. We have an impressive track record of exceeding our enrollment goals and maintaining nearly a 90% client retention rate.

With our collaborative approach and commitment to quality, Linical expertly guides you through each step of the process, from early-phase research to large-scale global studies. With Linical, you can overcome obstacles, expedite timelines, save valuable money, and achieve your goals without compromising quality.

Successful clinical trials start with Linical.

Don’t let the complex clinical development journey hold you back. With Linical, you can overcome obstacles, save valuable time and money, and reach your goals. 

01 Request a proposal

We start by listening to your needs and understanding your goals to ensure we’re the right CRO for you.

02 Get a plan for success

We propose solutions that proactively tackle obstacles, optimize your trial design, and position you for success every step of the way.

03 Execute with confidence

We’ll guide you through each phase of the process, offering personalized support and a full range of services to help you achieve a successful trial. We are not a “one size fits all” CRO.

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