Company : Clinigene International
Department :Clinical Operations
Position : Clinical Research Associate
Location : Bangalore
Qualification : Post graduate in life science / B.D.S / MBBS / M. Pharmacy / B. Pharmacy.
Experience : 2 - 4 years.
No. of Position : 4
Job Description
Department :Clinical Operations
Position : Clinical Research Associate
Location : Bangalore
Qualification : Post graduate in life science / B.D.S / MBBS / M. Pharmacy / B. Pharmacy.
Experience : 2 - 4 years.
No. of Position : 4
Job Description
- Assist Project Manager with feasibility analysis and identification, and selection of investigators.
- Assist Project Manager in planning the conduct of the clinical trial and developing trial management systems.
- Assist in preparation of study budgets.
- Prepare documents for ethics committee and regulatory submissions.
- Assist in the planning and coordination of investigator meetings and prepare presentation materials and present information at these meetings.
- Assist in the management of recruitment strategies, when necessary.
- Assist in the management and preparation of tracking documents.
- Assist Project Manager with management of study drug/supply/equipment delivery, shipment, inventory, and accountability.
- Create documents required by the project team prior to the start of the study (e.g. protocols, feasibility questionnaires, patient tracking tools, etc.).
- Prepare, plan, organize and conduct pre-study (site selection) visits and report on these visits to Project Manager to assist in site selection.
- Prepare, plan, organize and conduct site initiation visits.
- Collect and review essential documents from study sites.
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