Medical Monitor/ CRA
Ahmedabad, Gujarat
Veeda Clinical Research
Job Description
1 Protocol preparation and review
2 ICD preparation and review
3 Preparation of investigator brochure, if required
4 Preparation of safety management plan
5 Review of reports and documents of patients prior to screening and providing opinion
6 Providing adequate response to investigator’s query related to medical aspects
7 Perform Site visit to train the site and do medical monitoring
8 Review of adverse event, serious adverse events and pregnancy forms
9 Preparation of appendix XI, CIOMS, etc to be circulated to DCGI and Sponsor
10 Coding of adverse event as per Meddra
11 Review of AE coding as per NCI CTC AE criteria
12 Lab report review to check patient eligibility
13 Reconciliation of all SAE
14 Providing therapeutic training to monitors and site team
15 Others as required
2 ICD preparation and review
3 Preparation of investigator brochure, if required
4 Preparation of safety management plan
5 Review of reports and documents of patients prior to screening and providing opinion
6 Providing adequate response to investigator’s query related to medical aspects
7 Perform Site visit to train the site and do medical monitoring
8 Review of adverse event, serious adverse events and pregnancy forms
9 Preparation of appendix XI, CIOMS, etc to be circulated to DCGI and Sponsor
10 Coding of adverse event as per Meddra
11 Review of AE coding as per NCI CTC AE criteria
12 Lab report review to check patient eligibility
13 Reconciliation of all SAE
14 Providing therapeutic training to monitors and site team
15 Others as required
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