sandhya bhor

Knowledge about Clinical Trial Documentation, Research Regulation, Regulatory submissions, Site Monitoring. Skilled in Electronic Data Capture (EDC), Clinical Data management (CDM), Good Clinical Practice (GCP) and Clinical Research. I have worked on various therapeutic Indications Like, Gastroenterology (Phase 3), Dermatology & Oncology (Phase 4), Lung Cancer (Phase 4), Breast Cancer (Phase 4), Prostate cancer(Phase 3), Gastric cancer(Phase 3), Hep B (Phase3), UCCD Disease.

Identifying/Selecting an investigator who will be responsible for the conduct of the trial at the site. Verify that IRB operates and complies as per GCP & applicable regulatory requirements. Perform on site clinical monitoring visits which includes: Document review, ensuring accurate data recording, Source data verification, assess adherence to the protocol of a clinical trial in accordance with GCP guidelines, and CRO’s/Sponsor SOP’s.

Identifying/Selecting an investigator who will be responsible for the conduct of the trial at the site. Verify that IRB operates and complies as per GCP & applicable regulatory requirements. Perform on site clinical monitoring visits which includes: Document review, ensuring accurate data recording, Source data verification, assess adherence to the protocol of a clinical trial in accordance with GCP guidelines, and CRO’s/Sponsor SOP’s.

Initially I started work as Clinical Research Co-Ordinator therefore I have hand on practical experience about site management and know how trails has been conducted in hospitals.

Clinical Research