Are you ready to kickstart or advance your career in clinical research? Apotex Inc., a global leader in affordable healthcare solutions, is seeking a Clinical Research Associate for its Bioequivalence Center in Bangalore. With a legacy of excellence in producing high-quality medicines for over 75 countries, Apotex offers an inclusive and growth-oriented environment for its employees.
About Apotex Inc.
Apotex Inc., headquartered in Canada, is renowned for its comprehensive approach to healthcare through the development and distribution of generic, biosimilar, and specialty products. Supported by a dedicated workforce of 7,200 professionals globally, Apotex emphasizes research, innovation, and affordability in healthcare solutions.
Key Responsibilities in the Role
As a Clinical Research Associate at Apotex, you’ll play a crucial role in ensuring the successful execution of clinical studies. Your responsibilities will include:
- Adhering to Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) in compliance with regulatory standards.
- Managing the entry, retrieval, and review of study data for report preparation and compliance with CDISC datasets.
- Coordinating internal and cross-functional communications for study-related activities.
- Handling clinical study materials, including receiving, issuing, and storage.
- Ensuring readiness for audits through meticulous documentation practices.
- Assisting with reconciliation of study data and preparation of clinical reports.
- Supporting activities outlined in the study-specific protocol under the guidance of Clinical Operations Management.
- Maintaining compliance with safety, quality, and organizational policies.
Qualifications and Skills
To excel in this role, Apotex seeks candidates with the following:
Educational Background
- A degree in B.Pharm, Pharm D, or B.Sc. in Life Sciences or related fields.
Key Skills and Attributes
- Proficiency in Microsoft Office tools.
- Strong communication skills.
- Ability to work collaboratively and flexibly.
- A commitment to ethical practices and adherence to organizational values like Collaboration, Courage, Perseverance, and Passion.
Experience
- Candidates with 0-2 years of experience in clinical research are encouraged to apply, making it an excellent opportunity for freshers and entry-level professionals.