Clinical Research Associate
1 month ago
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)
- 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.
**Salary**: ₹12,073.90 - ₹28,792.79 per month
**Benefits**:
- Internet reimbursement
Schedule:
- Day shift
Ability to commute/relocate:
- Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
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