Job Description

Clinical Trial Coordinator - Mumbai for Pharma Company Qualification: A post-graduate in life sciences/PharmD GCP trained and Certified Required Skills: Thorough understanding of drug development process and expertise in NDCT rules & ICH-GCP/Indian GCP Knowledge of clinical trial regulation of US FDA, EMEA, NDCT rules, ICMR guidelines. Good leadership qualities and skills. : Ability to communicate properly between the physician, patient & the site head. Assist the Site Head in the managing the Site to ensure ethical conduct of research activities. Assist Site Head in evaluates protocols, policies and procedures regarding research projects and studies. Maintains pertinent records and documentation. Maintenance of Investigator Master File as per good documentation practices & SOP including generation of source documents. Oversight of Site Initiation Visit, Monitoring Visits, Site Closeout Visit. CRF, e-CRF entry, Data Query resolution. Assist the pharmacist in drug accountability and temperature maintaining logs. Endow the required file notes, weekly and monthly and monthly report to the reporting authority. Tracking the status of all study activities. Report to the Site Head daily and take advice for further action. Responsible for the Ethics committee activities. Coordination of Clinical trial archival documents. Coordination Pre-audit, Audit, Post Audit preparation for NABH accreditation. Job Type: Full-time Salary: Up to 400,000.00 per year Benefits:

• Cell phone reimbursement

Schedule:

• Day shift

Supplemental pay types:

• Commission pay
• Performance bonus

Ability to commute/relocate:

• New Delhi, Delhi: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Clinical research: 3 years (Preferred)

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