Key Responsibilities:

1. Oversee BA/BE Studies:
   • Manage the smooth operation of bioavailability/bioequivalence (BA/BE) studies.
   • Collect and compile research data, ensuring data integrity.
2. Research Participant Engagement:
   • Inform participants about the study during the informed consent process.
   • Monitor research participants to ensure adherence to study protocols.
3. Study Administration:
   • Participate in the administration of investigational products.
   • Coordinate with pathology labs for screening, post-study analysis, and follow-ups.
4. Compliance and Documentation:
   • Ensure adherence to ICH-GCP, GLP, FDA guidelines, and in-house SOPs.
   • Maintain study timelines and detailed records of studies, including case report forms (CRFs) and investigational material accountability.
   • Assist with subject enrollment and ensure study supplies and equipment are prepared before study initiation.
5. Coordination and Communication:
   • Engage with study staff and subjects to address concerns and ensure documentation is completed on time.
   • Facilitate timely project submission to meet stringent deadlines.

Qualifications and Experience:

• Educational Requirements:
  • B. Pharm, M. Pharm, or M.Sc. in Clinical Research.
• Experience:
  • 2-8 years of experience as a Clinical Research Coordinator, particularly in BA/BE centers.

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