Trainee CRA (Maharashtra)

Eazyhire – Date posted: 10 Jun 2015
II] CLINICAL TRIAL :- [Initiation, Monitoring and Closeout Activities]

1. Protocol preparation.

2. Pre-Study activities (site selection, coordinating with the investigator etc).

3. Assisting in submission of documents to the Ethics committee.

4. Monitoring the trial & trial related documents (on-site & off- site).

5. Statistical Analysis.

6. Report Writing & Publication.

III] REGULATORY

1. Preparation of required documents (Rationale).

2. Literature support for regulatory queries.

3. Justifications for product combination.

4. For Regulatory submission Co-ordination and obtaining all the doctors required for DCGI submission- CRDs, R& D and Regulatory.

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