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Clinical Study Coordinator Level 3 Course & Certification
Intermediate
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4.7
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97% Recommended
Updated 2026
3 hours
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1 x Clinical Study Coordinator Level 3
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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), FDA 21 CFR 312, EMA CTR 536/2014, MHRA inspection priorities and ICH safety reporting guidelines, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by senior Clinical Study Coordinators and site managers to ensure that learners can lead complex trials with confidence.
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About
The Clinical Study Coordinator Level 3 Course is designed for experienced clinical research professionals to develop expert-level site coordination and study management skills. It focuses on leading complex clinical trial activities, ensuring regulatory compliance, and maintaining high standards of quality, safety, and operational excellence at the site level.
This course covers advanced coordination responsibilities including multi-study management, high-complexity patient and protocol oversight, critical query and deviation management, audit and inspection readiness, risk-based site management, and strengthened collaboration with investigators, sponsors, and regulatory bodies. It also emphasizes leadership in GCP compliance, documentation excellence, and proactive problem-solving in clinical trial operations. Upon completion, learners receive a certification demonstrating advanced competency as a Clinical Study Coordinator Level 3.
Who Should Enrol?
- Experienced Clinical Study Coordinators
- Senior Clinical Research Coordinators
- Clinical Trial Coordinators handling multiple studies
- Site Operations and Clinical Research Leads
- Life Science, Pharmacy, Nursing, and Medical professionals with site experience
- Professionals managing complex or multi-site clinical trials
- Individuals progressing toward senior site management roles
What you will learn
Develop advanced Clinical Study Coordinator (Level 3) leadership skills to transition from site coordinator to independent site leader with full operational ownership of clinical trial activities.
Gain expertise in IRB/EC lifecycle management, regulatory submissions, documentation excellence, delegation practices, and maintenance of inspection-ready study records.
Master investigational product (IP) management, FDA regulatory requirements, protocol deviation handling, CAPA processes, and advanced subject compliance to ensure trial integrity.
Strengthen capabilities in audit and inspection readiness, site leadership, cross-functional coordination, and scenario-based decision-making to manage complex, high-risk clinical trial environments effectively.
Course Syllabus
- From Coordinator to Site Leader
- Leadership Behaviours
- Cross-functional Mastery
- Advanced Operations
- Types of IRB / EC
- Review Types
- Submission Excellence
- Lifecycle Management
- Managing Delays & Recovery
- ALCOA+ Principles
- Essential Documents
- Inspection-grade Binder
- Common Pitfalls
- Delegation Log Mechanics
- Training Documentation
- Staff Change Management
- Delegation/Training Pitfalls
- Form 1572 — The Statement of Investigator
- Financial Disclosure
- Investigator Responsibilities (21 CFR 312)
- Common Audit Issues
- IP Receipt & Storage
- Dispensing & Subject Use
- Cold Chain & Excursions
- End-of-Trial Reconciliation
- What is a Protocol Deviation
- Root-Cause Analysis
- CAPA — Corrective & Preventive Action
- Trending & Patterns
- Assessing Adherence
- Managing Non-Compliance
- Data Integrity & Compliance
- Special Populations
- Types of Audit & Inspection
- Top 10 Audit Findings
- Inspection-Day Choreography
- Always-Ready Posture
- Multiple-Study Management
- Coaching Junior CRCs
- Preventing Operational Failure
- Succession & Continuity
- Audit & Inspection Scenarios
- Deviation & CAPA Scenarios
- IP & Logistics Scenarios
- Sponsor & IRB Scenarios
- Site Leadership Scenarios
- Career-Risk Scenarios
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