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Clinical Research Coordinator

3 weeks ago

Guwahati, India Smolt Life Sciences LLP Full time

1. Coordinate with study monitor during the site selection, initiation, routine monitoring visits and site close out visit activities

2. Developing, implementing and maintaining study documents, timelines, files, communication tools, and systems used in conducting a project.

3. Maintain the study related Logs and Forms: Screening, Enrolment, Drug Accountability, Temperature and other communication logs.

4. Follow up with study team for timely completion of the source documents and ensuring that all the relevant information required in the CRF are present in the source document.

5. Screening, Enrolment, Drug Accountability, Temperature and other communication logs

6. Follow up with study team for timely completion of the source documents and ensuring that all the relevant information required in the CRF are present in the source document

8. Coordinate Screening and recruitment of patients based on protocol eligibility criteria. Coordinate all patient-related appointments

10. Ensure proper follow-up until proper resolution

11. Expertise in handling “E-Systems” of clinical trials like ECRF

14. Responsible for the management of study materials and investigational product: ordering, tracking, storage, dispensing, reconciliation and destruction

15. Coordinate all lab related activities between Local/Central Laboratory and Courier for shipment of Samples.

16. Updating and maintaining the Investigator Site File and sending progress reports to CRO

17. EC related study documents submissions and notifying all AE’s and SAE’s and other applicable regulatory requirements within the timelines

18. Immediately report any serious adverse events (SAEs) to the PI and to sponsor, IRB, and other regulatory requirements

**Job Type**: Contractual / Temporary
Contract length: 12 months

**Salary**: ₹15,000.00 - ₹20,000.00 per month

Schedule:

- Day shift