Clinical Research Associate
This position will oversee the clinical trial process from startup activities to site close out including onsite monitoring across a range of therapeutic areas.
The incumbent should be Doctorate/Master's/Bachelors Degree in Science with minimum two years of experience on Phase I/II/III trials is must in the capacity of CRA either in CRO or a bio-pharmaceutical company. Basic understanding of the drug development process and understanding of clinical research process and ICH GCP is must.
The core responsibilities for the position would be Site Monitoring:
This position will oversee the clinical trial process from startup activities to site close out including onsite monitoring across a range of therapeutic areas.
The incumbent should be Doctorate/Master's/Bachelors Degree in Science with minimum two years of experience on Phase I/II/III trials is must in the capacity of CRA either in CRO or a bio-pharmaceutical company. Basic understanding of the drug development process and understanding of clinical research process and ICH GCP is must.
The core responsibilities for the position would be Site Monitoring:
- Perform study site qualification visits, participate/conduct investigator's meeting and site initiation visits in coordination with the project manager and/or medical monitor
- To ensure all assigned studies follow SIRO/applicable SOPs, GCP and local regulations. Ensure regulatory documents are available, complete and current and submitted as per timelines.
- To identify, define, coordinate and conduct site study training. Perform regular monitoring visits to site, prepare monitoring reports and maintain audit readiness at the site level.
- Responsible for recruitment and propose alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines.
- To resolve all data queries or other study related queries from the site within timeframe.
- Conduct site close out and assure appropriate archival of controlled documents.
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