Clinical Trial Coordinator at Ahmedabad for Pharma

7 days ago

Ahmedabad, India People Alliance Human Resource Development Foundation Full time

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.

**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**
+91 7223810246

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