Clinical Research Associate
Location: Bangalore, KA, IN, 560099
Company: Apotex Inc.
About Apotex Inc.
Apotex Inc. is a leading Canadian-based global health company committed to delivering high-quality, affordable medicines to patients worldwide. With nearly 7,200 employees globally, we specialize in manufacturing, R&D, and commercial operations. Our products, including generic, biosimilar, and specialty medicines, are available in over 75 countries.
Learn more at: www.apotex.com
Job Summary
We are seeking a Clinical Research Associate to join our team. The successful candidate will ensure the execution of clinical studies and related activities in compliance with Good Clinical Practices (GCP), Good Laboratory Practices (GLP), regulatory requirements, and Apotex’s Standard Operating Procedures (SOPs).
Key Responsibilities
- Perform clinical study tasks following Apotex’s SOPs, GCP guidelines, and regulatory requirements.
- Enter study data into required formats/databases for report table preparation and CDISC datasets.
- Manage data collection, recording, verification, and storage systems.
- Review report tables and assist in data reconciliation.
- Handle requisition, receipt, and accountability of study forms.
- Organize files and clinical data for entry into databases or required formats.
- Collaborate with internal and cross-functional teams for study-related activities.
- Handle clinical study materials, including receipt, issuance, and storage.
- Maintain readiness for regulatory audits through adherence to good documentation practices and compliance with relevant SOPs.
- Support departmental activities to ensure a safe and efficient work environment.
Required Skills and Qualifications
Education
- B.Pharm, Pharm D, or B.Sc. in a Life Sciences-related field.
Skills and Abilities
- Proficiency in MS Office.
- Strong communication skills.
- Flexibility to work on various tasks as required.
Experience
- 0–2 years in Clinical Research.
Why Join Apotex?
- Work in a dynamic, inclusive environment that values Collaboration, Courage, Perseverance, and Passion.
- Opportunities for professional growth and development.
- Support for employees requiring accommodations during the recruitment process.
Be part of a team dedicated to making a difference in global healthcare.
