Job description:
1. Maintaining the source documents, CRFs, Investigator Site File and other study related documents according to ICH-GCP guidelines.
2. Completing the eCRF.
3. Maintenance of Investigational Product according to the specific temperature.
4. Preparing for site qualification visits, initiation visits, monitoring visits and site close out visits.
5. Organizing ethics committee meetings.
6. Completing the review forms and submitting all study related documents to EC.
7. Coordinating with the local labs, central labs.
8. Assistance in Safety Reporting within the required timelines.
9. Assistance in patient selection and recruitment. .
10. Assistance in Informed Consent Process.
PG:M.Sc - Any Specialization, Microbiology, M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology
1. Maintaining the source documents, CRFs, Investigator Site File and other study related documents according to ICH-GCP guidelines.
2. Completing the eCRF.
3. Maintenance of Investigational Product according to the specific temperature.
4. Preparing for site qualification visits, initiation visits, monitoring visits and site close out visits.
5. Organizing ethics committee meetings.
6. Completing the review forms and submitting all study related documents to EC.
7. Coordinating with the local labs, central labs.
8. Assistance in Safety Reporting within the required timelines.
9. Assistance in patient selection and recruitment. .
10. Assistance in Informed Consent Process.
Desired Candidate Profile
Education-
UG: B.Tech/B.E. - Any Specialization, Bio-Chemistry/Bio-Technology, B.Sc - Any Specialization, MicrobiologyPG:M.Sc - Any Specialization, Microbiology, M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology
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