Clinical Operations
- Site identification, feasibility, evaluations, selection and report preparation.
- To assist in organizing investigators meeting
- To coordinate with manufacturing units, R & D and arrange investigational product and trial materials
- Verification of translated and back translated ICDs, subject diaries and patient information materials.
- To coordinate with legal cell to execute agreements with investigators and vendor
- To arrange trial specific insurance certificates from insurance company
- Coordinating submission of regulatory binder to DCGI office with regulatory team
- Coordinate clinical trial activities of outsourced projects with contract research organisation (CRO)
- Coordinating Ethics Committee submissions through Principal Investigator
- To perform site initiation and report preparation
- Site personnel training on various guidelines as per industry standards of clinical trials
- To perform site monitoring and report preparation and On site source data verification
- Ensuring transfer of CRF & diary pages to DM vendors and coordinating query resolution activities.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Research Associate/Scientist
Role: Clinical Research Associate/Scientist
Keyskills: Site Initiation, D, Clinical Research, Clinical Operations, Crf, Clinical Trials, Cro, R, Site Monitoring, Query Resolution