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
