Clinical Research Co-ordinator

2 weeks ago

Bengaluru, Karnataka, India St Johns Research Institute Sjri Full time
Job Description

Roles and Responsibilities:

Coordinate in screening, Audio-Video consenting, enrolment, periodic study visits and close out visit.

- 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 maintain inventory of Study consumables like Investigational product handling, storage, dispensing, accountability, tracking temperature, calibration of equipment s, sample centrifugation, courier of documents and lab samples shipment.
- Timely preparation, 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 SAEs
- Assist in resolving IEC, 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

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