Clincial Research Associate/ CRA vacancy @ Bharat Biotech International Ltd, D- 8

Job Description

Ethics Committee submissions/DCG(I) submissions. Visits like Site Evaluation, Site Initiation, Interim Monitoring visit and Study close-out visit. Following up on previously identified issues like Informed Consent, outstanding corrections on forms and missing documents in Regulatory files. Clinical Trial Updates from all the sites and addressing to the core issues. Maintaining Trial Master File (TMF). Preparing Clinical Trial Documents including Investigator Brochure, Clinical Trial Agreements, PSURs (Periodic Safety Update Report). Preparation of SOPs. Verification of eligibility of subjects being enrolled by the Investigator. IP (Investigational Product) review and accountability. Answering to DCG (I) queries/Site queries. Designing PMS Forms & Informed Consent Forms Apply now for this job