Clinical Research Associate

7 days ago

Delhi, Delhi, India AURIGA RESEARCH PVT LTD Full time ₹ 3,50,000 - ₹ 7,00,000 per year

Key Responsibilities

1. Study Monitoring

  • Conduct site initiation, routine monitoring, and close-out visits.
  • Ensure adherence to study protocol, GCP guidelines & regulatory requirements.
  • Verify informed consent forms and ensure ethical compliance.
  • Review and validate source documents, CRFs, and eCRF entries.
  • Identify protocol deviations and ensure corrective actions are implemented.

2. Site Management

  • Train investigators, coordinators, and site staff on study procedures.
  • Maintain oversight of site performance and subject recruitment status.
  • Ensure availability of study supplies, trial materials, and drug accountability.
  • Build strong relationships with investigators and site teams.

3. Documentation & Compliance

  • Maintain Trial Master File (TMF) and site-level documentation.
  • Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
  • Prepare monitoring reports and follow-up letters.
  • Ensure data integrity and compliance with SOPs, ICH-GCP, CDSCO/EMA/FDA requirements.

4. Coordination & Communication

  • Work with project managers, data managers, and medical monitors.
  • Participate in investigator meetings and internal team meetings.
  • Provide feedback and updates on site status and trial progress.

Job Type: Full-time

Pay: ₹30, ₹40,000.00 per month

Benefits:

  • Health insurance
  • Provident Fund

Work Location: In person

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