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Clinical Trial Coordinator at Ahmedabad for Pharma
1 week ago
Qualification:
- A postgraduate 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, eCRF 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 Preaudit, Audit, Post Audit preparation for NABH accreditation.
Salary:
Up to ₹400,000.00 per year
Benefits:
- Cell phone reimbursement
Schedule:
- Day shift
Supplemental pay types:
- Commission pay
- Performance bonus
Speak with the employer
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