Course Description
Program Overview
The Applied CRA Clinical Trial Monitoring Internship™ is a 12-week remote experiential program designed to bridge the gap between learning clinical research concepts and applying them in realistic clinical trial monitoring situations. Through three progressively challenging simulated clinical trial projects in Cardiovascular, Oncology, and Infectious Diseases, participants assume the role of a Clinical Research Associate and work with realistic study materials including protocols, source documents, eCRFs, laboratory records, safety documentation, investigational product records, and site documentation.
Participants independently review study records, assess participant eligibility, perform SDR/SDV activities, identify discrepancies and protocol deviations, review AE/SAE and investigational product documentation, develop professional data queries, and prepare CRA monitoring deliverables. Following assignment submission, participants take part in instructor-led CRA debriefs, where they discuss findings, justify monitoring decisions, assess risk, determine appropriate follow-up and escalation, and receive individualized feedback.
The experience progresses from foundational monitoring activities to increasingly complex scenarios involving oncology dosing and imaging, microbiology and specimen processing, randomization and blinding, cold-chain management, and CAPA/root-cause assessment. This is not simply a program about what CRAs do — it is an opportunity to practice thinking, documenting, and communicating like a CRA. Foundational knowledge of Good Clinical Practice (GCP), clinical trial operations, and the CRA role is recommended before enrolling; eligibility is determined during enrollment based on prior clinical research education and experience.
Program at a Glance
Live • Remote • Instructor-Guided
12-Week Applied Experience
Three months of progressive CRA monitoring practice
Instructor-Guided Experience
Independent assignments with live expert debriefs
3 Therapeutic-Area Projects
Cardiovascular • Oncology • Infectious Disease
Tuition US$1,995
Professional CRA Portfolio
Build interview-ready evidence of your applied skills
Certificate + Competency Transcript
Document competencies across all 3 projects
Career Success Package – INCLUDED
ATS Résumé • LinkedIn • Job Search • Mock Interview
Faculty Director: Coming Soon
Meet your expert program lead
Learning Objectives
Upon successful completion of the program, participants should be able to:
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Conduct structured reviews of simulated source documents and eCRFs.
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Apply Source Data Review (SDR) and Source Data Verification (SDV) principles.
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Evaluate participant eligibility against protocol requirements.
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Identify source/eCRF discrepancies and develop appropriate data queries.
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Identify and assess protocol deviations.
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Review AE/SAE documentation from a CRA monitoring perspective.
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Review investigational product accountability, storage, and related documentation.
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Prioritize monitoring findings according to participant safety, rights, data integrity, and protocol compliance.
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Prepare professional Monitoring Visit Reports, follow-up letters, and action trackers.
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Assess oncology dosing, dose modifications, and imaging-related documentation within appropriate CRA boundaries.
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Evaluate microbiology, specimen-processing, randomization/blinding, and cold-chain documentation.
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Apply root-cause and CAPA principles to potential systemic site issues.
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Demonstrate appropriate CRA communication, escalation, documentation, and professional boundaries.
Who Should Attend
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Aspiring Clinical Research Associates
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Clinical Research Coordinators seeking to transition into CRA roles
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Individuals who have completed CRA or GCP training and want applied monitoring practice
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Internationally educated physicians, pharmacists, nurses, and other healthcare professionals transitioning into clinical research
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MSc, PhD, and life-science graduates pursuing clinical research careers
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Clinical research professionals returning to the industry
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Candidates preparing for CRA interviews who want realistic monitoring scenarios they can confidently discuss
Course Outline
Month 1 - Cardiovascular Clinical Trial Monitoring
Foundation Level
The first project establishes the core monitoring disciplines required to approach a clinical trial site systematically and determine what the evidence shows, why a finding matters, and what the CRA should do next.
• Key Activities: Protocol & Site Documentation • Participant Eligibility • Source/eCRF Review • SDR/SDV • Data Discrepancies • Query Development • Protocol Deviations • AE Review • Investigational Product Accountability • Action-Item Management
• Key Deliverables: Monitoring Visit Report • Follow-Up Letter • Action Tracker • Eligibility Assessment • Source/eCRF Assessment
Month 2 - Oncology Clinical Trial Monitoring
Intermediate Level
The second project introduces a more complex oncology trial environment where eligibility, laboratory requirements, imaging, dosing, safety, and pharmacy documentation become increasingly interconnected. Participants progress from reviewing isolated discrepancies to assessing patterns, clinical trial risk, and potential systemic site issues.
• Key Activities: Complex Eligibility • Laboratory & Source/eCRF Reconciliation • Imaging/RECIST-Related Review • Dosing & Dose Modifications • AE/SAE Review • Pharmacy/IP Review • Protocol Deviations • Risk Prioritization • Root-Cause & CAPA Development
• Key Deliverables: Oncology Monitoring Visit Report • Dose Modification Assessment • Pharmacy/IP Assessment • CAPA • Follow-Up Letter • Action Tracker
Month 3 - Infectious Diseases
Advanced Capstone Level
The final project challenges participants to integrate multiple monitoring domains while maintaining appropriate CRA professional boundaries. Participants encounter time-sensitive and operationally complex monitoring situations requiring them to prioritize competing risks and determine appropriate monitoring actions.
• Key Activities: Specimen Collection & Processing • Microbiology Review • Antimicrobial Eligibility • Randomization & IRT • Study Blinding • AE/SAE Assessment • Missed-Dose Review • Cold-Chain/IP Assessment • Complex Protocol Deviations • Integrated Site Risk • Root-Cause & CAPA
• Capstone Deliverables: Monitoring Visit Report • Follow-Up Letter • Action Tracker • Microbiology/Specimen Assessment • Blinding/IRT Assessment • Cold-Chain/IP Assessment • CAPA • Final Site-Risk Assessment
Interactive Activities
- •Weekly cycle across all three projects: assignment release, independent monitoring review, CRA deliverable submission, instructor-led CRA debrief, remediation where required, then progression to the next project (submit first, debrief second)
- •Simulated clinical trial environment: protocols, source documents, eCRFs, laboratory and microbiology records, AE/SAE documentation, investigational product and pharmacy records, dosing and imaging records, randomization/IRT documentation, cold-chain records, and monitoring trackers/reports
- •Competency-based assessment through independent monitoring assignments, CRA deliverables, instructor-led debrief participation, and a final Infectious Disease capstone assessment
- •Career Success Package at no additional cost— INCLUDED: ATS-Optimized CRA Résumé, LinkedIn Profile Optimization, CRA Job Search and CRA Mock Interview & Role-Play
- •Upon Successful Completion, Participants Receive: CRTA Certificate of Completion, Three-Therapeutic-Area Competency Transcript, CRA Professional Portfolio, Three Completed Monitoring Projects, and Career Success Package — Included.
