Central Clinical Data Coordinator

5 days ago

Prahlad Nagar Ahmedabad Gujarat, India Groovyweb Full time

Collect, enter, analyze, and manage data from clinical studies
- Maintain training and understanding of FDA, GCP, GDP, IATA, and Sponsor specified systems/processes
- Maintain working knowledge of current FDA GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
- Ensure the quality of data submitted from assigned study sight, while, assuring timely entry into corresponding study database, submission of data and appropriate reporting and follow-up of data collection
- Ensure the internal processes follow the study protocol, amendment(s), while being in line with
- GCP, GDP and regulatory guidelines
- Ensure data collected is accurate, legible, contemporaneous, original, authentic, and complete
- Resolve any discrepancies, queries and events in-line with company and study protocols
- Complete eDiary functions
- Document clinical trial progress to ensure completeness of documentation and adherence to trial and/or project timelines
- Contribute to, and/or generate requested reports for management
- Be accountable for data collection process
- Participate in required trainings as set forth by the company, department, sponsors, and trials
- Being prepared for and available at all the necessary company meetings and monitoring visits for their assigned protocols
- Submitting required administrative paperwork per company timelines
- Any other matters as assigned by management related to data collection for responsible trials

**Salary**: ₹13,300.21 - ₹100,000.00 per month

Schedule:

- US shift

**Experience**:

- total work: 1 year (preferred)

Ability to Commute:

- Prahlad Nagar, Ahmedabad, Gujarat (required)

Ability to Relocate:

- Prahlad Nagar, Ahmedabad, Gujarat: Relocate before starting work (required)

Work Location: In person

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