Clinical Research Associate
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Job summary
A Clinical Research Organization Client is seeking an experienced Clinical Research Associate (CRA) to support clinical trial monitoring, site readiness, and regulatory compliance for upcoming studies. The role will initially operate on a retainer/part-time basis during study preparation, transitioning to full engagement once clinical studies are
Min Qualification:
Degree
Experience Level:
Entry level
Experience Length:
2 years
Job descriptions & requirements
Responsibilities:
- Monitor clinical trial sites to ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements
- Conduct Site Qualification Visits (SQV), Site Initiation Visits (SIV), Monitoring Visits (IMV), and Close-Out Visits (COV)
- Perform Source Data Verification (SDV) and ensure data accuracy and integrity
- Maintain Trial Master File (TMF / eTMF) documentation to ensure inspection readiness
- Track protocol deviations, adverse events, and study-related issues
- Support investigator training and site readiness activities
- Collaborate with investigators, site coordinators, and clinical operations teams
- Prepare monitoring reports and follow-up documentation
Requirements:
- Degree in Health Sciences, Medicine, Pharmacy, Nursing, or related field
- Minimum 2–4 years of experience in clinical research or clinical trial monitoring
- Strong understanding of ICH-GCP guidelines and clinical trial processes
- Experience with site monitoring and regulatory documentation
- Familiarity with EDC systems and clinical documentation management
- Strong organizational and communication skills
- Ability to manage multiple sites and timelines
Preferred Experience:
- Prior experience supporting multi-site clinical trials
- Experience working with CROs, sponsors, or research institutions
- Familiarity with TMF/eTMF systems and clinical trial management tool
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