Job Description
The major purpose of a Clinical Research Associate (CRA) is to ensure that clinical trials to be
conducted in compliance with regulatory requirements, ethical standards, GCP and the study
protocol.
Responsibilities:
- Acts as point of contact for communication between the team and external parties if any (i.e.
sponsor, central lab, PI)
- Charting of Site Initiation, Monitoring Plan
- Coordinate and distribute clinical study material to study sites
- Providing inputs for study protocol and CRF
- Coordinator with In-house/ Vendor/Pharmacist for IMP supply and shipments
- Supervise Clinical Research Activities
- Organize the IB, Protocol, CRF, ICF, Instruction manuals etc.
- Perform Site Identification and conduct feasibility studies
- Preparation and review of clinical trial related SOPs
- Presenting kick off meeting and project training to team members
- Perform projects SSV, SIV, SMV and SCV in timely manner
- Periodic monitoring to clinical trials sites
- Maintain updated site files and collection of essential documents
- Send follow up letter to sites and submit visit report to Project Manager
- Internal QC of study files/ documentation
- Archival of study documents
Regulatory & Ethical Affairs:
? Co-ordinate with sites for Ethics Committees Submission
? Updating about the trial status, such as investigator, site, SAE reporting and SCV
