The Clinical Research Associate (CRA) at Apotex will be responsible for executing study and system-related activities as per the established Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and regulatory guidelines. The role involves coordinating data management, ensuring compliance, and supporting cross-functional teams to ensure the smooth execution of clinical studies.
Job Responsibilities:
- Perform duties in alignment with Apotex Research Pvt. Ltd., Bioequivalence Center’s SOPs, GCP, regulatory guidelines, and Safe Work Procedures.
- Enter study data into required formats/databases, assist in report table preparation, and create CDISC datasets.
- Manage data collection, verification, storage, and retrieval systems.
- Review report tables and reconcile study data.
- Organize and manage clinical data and documents.
- Ensure the department’s readiness for regulatory audits by maintaining good documentation practices.
- Coordinate with internal and cross-functional departments for study-related activities.
- Handle Clinical Study Materials (receiving, issuing, storage).
- Perform study activities per protocol requirements and other duties as assigned by the Clinical Operations Management team.
- Comply with regulatory, safety, and ethical guidelines while demonstrating Apotex’s core values: Collaboration, Courage, Perseverance, and Passion.
Job Requirements:
Education:
- Bachelor’s degree in Pharmacy (B.Pharm), Doctor of Pharmacy (Pharm D), or B.Sc. in Life Sciences.
Skills and Abilities:
- Proficiency in MS Office applications.
- Strong communication and organizational skills.
- Flexible to work in varying conditions and schedules.
Experience:
- 0-2 years of experience in clinical research.
