Education:
UG - Any Graduate - Any Specialization,Graduation Not Required
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 09 Oct
Job Description
• Monitor the conduct of clinical trials, especially enrollment and quality of data.
• Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.
•Review CRF, Informed Consent Documents and query language/narratives.
• Conduct Qualification, Initiation, Interim and Closeout monitoring visits.
• Ensure complete and thorough study drug reconciliation.
• Manage monitoring reports, letters, query resolutions.
Ensure the integrity of data submitted on CRFs or other data collection
SAE reporting, follow up of SAE's and safety mailing to sites
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