Job opening as a Clinical Research Associate @ Genelife Mumbai For Freshers "D"

Clinical Research Associate

by Genelife Clinical Research in Mumbai

Experience: 0 to 5 yrs.  | Salary: INR 1,25,000 - 3,50,
000 P.A

Job Description

1. Perform the clinical monitoring aspect of designated projects in accordance with study specific procedures, applicable SOPs, and regulations.
2. Train team members on selected tasks.
3. Keep manager informed about work progress and any issues to avoid surprises. Requires some
interaction / supervision by Manager or assigned mentor.
4. Build relationships with investigators and site staff.
5. Participate in Investigator and other external or internal meetings as required.
6. Arrange on-site visits and logistics (e.g. travel arrangements).
7. Perform on site visits in accordance with the monitoring plan.
8. Conduct on-site study-specific training (if applicable).
9. Perform site facilities inspection.
10. Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
11. Monitor and maintain ICH-GCP compliance.
12. Responsible for the completeness and quality of the on-site files.
13. Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and
update at Initiation Visit and Monitoring Visit.
14. Update all relevant tracking system on an ongoing basis.
15. Generate visit/contact report in accordance with monitoring plan.
16. Code and scan Central File documents where applicable.
17. Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead.
18. Attend audits / Regulatory Inspection if requested.

Salary:

INR 1,25,000 - 3,50,000 P.A

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