- develop and write trial protocols (outlining purpose and methodology)
- present trial protocols to a steering committee
- design data collection forms, known as case report forms (CRFs)
- coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
- manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
- identify and assess the suitability of facilities to use as the clinical trial site
- identify/select an investigator who will be responsible for conducting the trial at the trial site
- liaise with doctors, consultants or investigators on conducting the trial
- set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
- train the site staff to trial-specific industry standards
- monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues




- verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
- collect completed CRFs from hospitals and general practices
- write visit reports and file and collate trial documentation and reports
- meet with team members to discuss on-going trials, results and any trends or adverse events
- ensure all unused trial supplies are accounted for
- close down trial sites on completion of the trial
- discuss results with a medical statistician, who writes technical trial reports
- archive study documentation and correspondence
- prepare final reports and occasionally manuscripts for publication.

Job Type: Full time

Pay: From ₹18,000.00 per month

Benefits:

- Paid sick time
- Provident Fund

Experience:

- total work: 1 year (Preferred)

Work Location: In person

📌 Clinical Research Coordinator (Vaishali Nagar)
🏢 Shalby Hospital
📍 Vaishali Nagar