Clinical Research Associate
4 weeks ago
Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out
- Managing and training site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
- Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
- Monitoring and documenting investigational product dispensing, inventory, and reconciliation
- Monitoring and documenting laboratory sample storage and shipment
- Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
- Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
- Reviewing data queries and listings, and working with the study centers to resolve data discrepancies
- Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues
**Salary**: ₹12,063.59 - ₹28,764.42 per month
**Benefits**:
- Internet reimbursement
Schedule:
- Day shift
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)
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