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Clinical Research Coordinator
1-4 years
Bangalore / Bengaluru
1 vacancy
Clinical Research Coordinator
St. John’s Research Institute
posted 5mon ago
Job Role Insights
Fixed timing
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Job Description
Experience: Maximum one year experience, Freshers are also acceptable
Roles and Responsibilities:
- Ensure that rights and well-being of a research participant is protected throughout the duration of the study.
- Coordinate with finance, legal-and regulatory team and assist in the preparation of CTAs " specific to the trials.
- Assure all study documentation is maintained by completing the source documents for each
- Patient and maintaining and updating Site master Files.
- Completing CRFs, e-CRFs on time and resolve data queries.
- EDC, InForm & Medidata data capture.
- Ensure and rnaintain inventory of Study consumables like Investigational product handling, storage, dispensing, accountability, tracking temperature, calibration of equipments, samples centrifugation, courier of documents and lab samples shipment.
- Timely pr6paration, notification and tracking of the Ethics committee submissions.
- Submission of the study progress, amendments, Protocol Deviations, AEs and SAEs to the ethics committee and sponsor in a timely manner.
- Coordinate with the investigator and the safety monitoring team at the time of SAE,s.
- Assist in resolving lEC, DCGI and FDA queries.
- Coordinate and participate in monitoring visits with sponsor/CRO and Facilitating inspections/audits.
- Follow up with patients and document in telephone contact report.
- Conduct study closeout visit and archive the documents.
- Maintain record of closeout studies and resolve the post closeout queries.
Employment Type: Full Time, Permanent
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