Job Description

• 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 Types: Full-time, Fresher Salary: 912,071.82 - 928,806.09 per month Benefits:

• Cell phone reimbursement
• Internet reimbursement

Schedule:

• Day shift
• Monday to Friday

Supplemental pay types:

• Performance bonus

Ability to commute/relocate:

• Pune, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Experience:

• total work: 1 year (Preferred)