Job description
ORGANISATIONAL OVERVIEW
JOB DETAILS
- Attend and facilitate Investigators Meeting.
- Training of Investigators on Protocol and other applicable regulatory guidelines.
- Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) in accordance with the protocol and other applicable regulatory guidelines.
- Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities
- Ensure compliance of all study-related requirements and its documents/data.
- Coordinate and distribute Clinical Study Materials to study sites
- Ensure calibration of all equipment to be used for the study.
- Act as a communication Link between LTR team and the site
- Maintain accurate and timely sponsor/site correspondence and communication
- Maintain updated Site Files and collection of project related documents during the site visits and maintain Site Master file
- CRF retrieval/ e-CRF review as per the project management plan and project manager instructions
- Archival of study documents in a timely manner at sites or at third party archival facility as per prevailing SOPs and project management plan.
- Any other responsibilities as assigned by the Supervisor/HOD/Management.