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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Clinical Operations Specialist Course & Certification
Intermediate
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4.7
★★★★★
97% Recommended
Updated 2026
3 hours
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2 points
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1 x Clinical Operations Specialist
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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), sponsor oversight expectations, and vendor governance practice, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by senior clinical operations leaders to ensure that learners can run programs at sponsor and CRO scale.
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About
The Clinical Operations Specialist Course is designed to provide a comprehensive understanding of clinical trial execution, coordination, and oversight across study sites and teams. It focuses on ensuring efficient trial delivery while maintaining compliance with Good Clinical Practice (GCP), regulatory requirements, and quality standards.
This course covers key areas including study start-up and maintenance, site management, vendor and CRO coordination, monitoring support, trial documentation, risk-based oversight, and issue resolution. It also emphasizes operational excellence, communication across stakeholders, inspection readiness, and adherence to clinical trial timelines and budgets. Upon completion, learners receive a certification demonstrating competency in clinical trial operational management.
Who Should Enrol?
- Clinical Operations Specialists and Associates
- Clinical Trial Assistants (CTAs)
- Clinical Research Associates (CRAs)
- Clinical Trial Coordinators and Managers
- Pharmaceutical and Biotechnology professionals
- CRO operations and project support teams
- Life Science, Pharmacy, Nursing, and Medical graduates
- Professionals transitioning into clinical trial operations roles
What you will learn
Understand the fundamentals of clinical operations, including trial lifecycle management, key stakeholders (sponsor, CRO, site), and performance metrics in clinical research.
Gain knowledge of protocol execution, regulatory compliance, GCP requirements, and study start-up activities such as feasibility, site selection, contracting, and activation.
Learn operational oversight skills including site management, patient recruitment and retention, data quality, safety reporting, and investigational product handling.
Develop expertise in risk management, vendor coordination, audit readiness, and cross-functional collaboration to ensure efficient and high-quality clinical trial delivery.
Course Syllabus
- What Clinical Operations Is
- The Role
- Sponsor vs CRO vs Site
- Trial Lifecycle
- Metrics & Performance
- Study Design Fundamentals
- Protocol Reading
- Operational Translation
- Protocol Amendments
- ICH GCP
- Regulatory Frameworks
- Compliance in Operations
- Inspection Expectations
- Feasibility & Site Selection
- Regulatory & Ethics Submissions
- Contracting & Budget
- Activation Gates
- Site Performance Management
- CRA Coordination
- Risk-Based Monitoring
- Site Communication
- Recruitment Planning
- Recruitment Intervention
- Retention
- Recovery
- Data Flow
- Query Management
- Data Integrity
- CDISC Standards
- AE & SAE Definitions
- Reporting Pipeline
- Safety Oversight
- Operational Interface
- QP Release & Import
- Cold Chain & Excursions
- Site IP Accountability
- Cross-Functional Coordination
- Vendor Management
- Sponsor Governance
- Risk Identification
- Risk Mitigation
- Risk-Based Quality Management
- Audit & Inspection Types
- Top 10 Audit Findings
- Inspection-Day Choreography
- Multi-Trial Management
- Timeline Optimisation
- Preventing Failure
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