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Clara Fargo
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Clinical Research Associate – Oncology Practitioner Course & Certification
Intermediate
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4.7
★★★★★
96% Recommended
Updated 2026
3 hours
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1 x Clinical Research Associate – Oncology Practitioner
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Each course includes:
Free eBook
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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), RECIST 1.1, iRECIST, FDA oncology center guidance and EMA oncology working party output, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by senior oncology CRAs and clinical scientists to ensure that learners can monitor oncology trials with confidence.
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About
The Clinical Research Associate – Oncology Practitioner Course is designed to provide specialized knowledge in monitoring and managing oncology clinical trials. It focuses on the unique complexities of cancer studies, including advanced protocols, patient safety considerations, and regulatory requirements specific to oncology research.,
This course covers oncology trial conduct, protocol compliance, safety reporting of oncology-specific adverse events, site monitoring, informed consent, and risk-based quality management. It also emphasizes Good Clinical Practice (GCP), communication with investigators, and inspection readiness in oncology trials. Upon completion, learners receive a certification demonstrating competency in oncology clinical trial monitoring.
Who Should Enrol?
- Clinical Research Associates (CRAs) interested in oncology
- Clinical Research Coordinators working in oncology trials
- Life Science, Pharmacy, Nursing, and Medical professionals
- Oncology site staff and clinical trial assistants
- Pharmaceutical and CRO professionals involved in oncology research
- Professionals transitioning into oncology clinical research
What you will learn
Understand the role of an Oncology CRA, including end-to-end clinical trial workflows, stakeholder management, and how oncology trials differ from other therapeutic areas.
Gain foundational knowledge of cancer biology, tumour classification, staging systems, and oncology treatment modalities to support accurate protocol understanding and site oversight.
Learn oncology-specific clinical trial design and endpoints, including RECIST criteria, survival and response measures, safety assessment, and dose modification principles.
Develop expertise in oncology trial operations such as site monitoring, data review, regulatory compliance, risk-based monitoring, audit readiness, and complex clinical decision-making scenarios.
Course Syllabus
- Who is an Oncology CRA?
- Why oncology is different
- End-to-end CRA workflow
- The Oncology CRA's stakeholder map
- Career pathway
- What is cancer?
- The Hallmarks of Cancer
- The genetics of cancer
- Major cancer types
- How cancer spreads
- Tumour microenvironment
- Histological classification
- Molecular classification
- TNM staging
- Other staging systems
- Grading systems
- Performance status
- Reading the pathology report
- Surgery & locoregional therapy
- Chemotherapy
- Targeted therapy
- Immunotherapy
- Cellular therapy
- Hormone therapy
- Combination regimens & treatment intent
- Phase 1 oncology trials
- Phase 2 oncology trials
- Phase 3 oncology trials
- Statistical design elements
- Special populations & Phase 4
- Survival endpoints
- Response endpoints
- RECIST 1.1 — the universal solid-tumour response criteria
- iRECIST and irRECIST
- Lugano, IMWG, RANO
- Surrogate endpoints, PROs, QoL
- Adverse event terminology
- CTCAE v5.0 — the grading language
- Haematologic toxicities
- Non-haematologic toxicities
- Immune-related adverse events (irAEs)
- AE/SAE reporting workflow
- Why dose modifications matter
- Hold criteria and recovery thresholds
- Dose reductions
- Permanent discontinuation
- Toxicity-specific dose modifications
- Treatment delays and missed doses
- The monitoring visit lifecycle
- Pre-visit preparation
- On-visit execution
- Monitoring reports & follow-up
- Site relationship management
- Hybrid monitoring
- Data integrity foundations — ALCOA+
- EDC and query management
- SDV depth and prioritisation
- Imaging data review
- Lab data review
- Drug accountability data
- ICH GCP E6(R3)
- FDA framework
- EMA / EU framework
- MHRA, PMDA, NMPA
- Informed consent
- Essential documents
- Why risk-based monitoring
- Risk identification
- Key Risk Indicators (KRIs)
- Quality Tolerance Limits (QTLs)
- Adaptive monitoring
- Audit and inspection types
- FDA BIMO inspections
- International inspections
- Preparing the site
- During the inspection
- Responding to findings
- Complex eligibility scenarios
- Safety crisis scenarios
- IP and pharmacy crisis scenarios
- Site relationship crises
- Decision frameworks
- Capstone scenarios
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