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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
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Clinical Study Coordinator — Level II Course & Certification
Intermediate
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4.7
★★★★★
97% Recommended
Updated 2026
3 hours
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1 x Clinical Study Coordinator — Level II
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Each course includes:
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to ICH-GCP E6(R3), ICH E2A, 21 CFR Part 11, EU Annex 11, UK SoECAT, US Medicare Coverage Analysis, and MHRA / FDA inspection guidance, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by senior clinical research coordinators, GCP auditors, sponsor study managers, and former MHRA / FDA inspectors. Every module pairs concept with case study, mistake catalogue, and 'what would you do?' scenario, so learners can rehearse the higher-judgement moves that distinguish Level II coordinators — not just recite the rule.
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About
The Clinical Study Coordinator Level 2 Course is designed to enhance the skills of clinical research professionals involved in site-level trial management. It builds on foundational knowledge and focuses on more complex coordination tasks required to ensure smooth, compliant, and high-quality clinical trial execution.
This course covers advanced study coordination activities, including study start-up and maintenance, patient visit management, regulatory document updates, query resolution, adverse event reporting, and effective communication with investigators, sponsors, and monitors. It also emphasizes Good Clinical Practice (GCP) compliance, audit readiness, and efficient site operations. Upon completion, learners receive a certification demonstrating their readiness for advanced Clinical Study Coordinator responsibilities.
Who Should Enrol?
- Clinical Study Coordinators (with Level 1 experience)
- Clinical Research Coordinators (intermediate level)
- Clinical Trial Assistants (CTAs) seeking progression
- Site-based clinical research staff
- Life Science, Pharmacy, Nursing, and Medical professionals
- Hospital research coordinators involved in clinical trials
- Professionals moving into advanced site coordination roles
What you will learn
Develop advanced CRC capabilities, including site leadership, multi-study coordination, stakeholder management, and operational decision-making at the clinical trial site.
Master protocol execution excellence by translating complex protocols into practice, minimizing deviations, and ensuring accurate and compliant trial conduct.
Strengthen expertise in recruitment, retention, and patient engagement strategies, including diversity inclusion, dropout management, and site-level enrolment optimization.
Gain advanced skills in data integrity, RBQM, safety management, financial awareness, audit readiness, and cross-functional collaboration to ensure high-quality, inspection-ready trial operations.
Course Syllabus
- From executor to site leader
- Managing multiple studies
- Managing stakeholders
- Leadership day-to-day
- Decoding complex protocols
- Operationalising the protocol
- Preventing protocol deviations
- Handling deviations when they occur
- Site-level recruitment strategy
- Retention as design discipline
- Managing dropouts
- Diversity and inclusion
- RBQM principles
- Preparing for monitoring visits
- Self-monitoring
- Managing high-risk site status
- ALCOA+ in daily practice
- Advanced query management
- Data quality risks
- Electronic systems & audit trails
- AE, SAE, SUSAR — the definitions that matter
- The 24-hour clock
- Documentation under pressure
- Escalation pathways
- What inspectors look for
- Documentation — inspection-ready by default
- Behaviour under inspection
- Handling findings
- How site budgets are structured
- Research vs standard of care
- Common financial errors
- Using the budget as a tool
- Working with CRAs
- Working with sponsors
- Working with vendors
- Conflict resolution
- Managing your workload
- Coaching junior coordinators
- Designing workflows that prevent errors
- Preventing burnout
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