Key Responsibilities:
- Oversee BA/BE Studies:
- Manage the smooth operation of bioavailability/bioequivalence (BA/BE) studies.
- Collect and compile research data, ensuring data integrity.
- Research Participant Engagement:
- Inform participants about the study during the informed consent process.
- Monitor research participants to ensure adherence to study protocols.
- Study Administration:
- Participate in the administration of investigational products.
- Coordinate with pathology labs for screening, post-study analysis, and follow-ups.
- 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.
- 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.