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Teva Pharmaceuticals

2-8 years

6,51,752 Per Year

navi Mumbai

B. Pharm, M. Pharm, or M.Sc. in Clinical Research.

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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

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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