Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
Job Title : Clinical Research Associate
Responsible for study management and execution of studies as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements
- Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
- Assists with Protocol, ICF writing, Case Report and Assists with the preparation of screening and study documentation for data collection
- Assists with follow-up appointments of Subjects
- Assists as required in the receipt, dispensation and inventory of test articles
- Prepares the clinic for study conduct ensuring all furniture, supplies and equipment ready for screening/clinic activities
- Ensures clinic staff activities for compliance with protocol and SOPs
- Assists with the Collection, reviewing and summarizing of clinical data and compilation of the clinical report
- Assist with the distribution of test articles to subjects as delegated by the Study Coordinator
- Conducts activities related to the transfer of subject samples
- Responsible for initiation and completion of archival of clinic study raw data, documents and records.
- Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- All other duties as assigned.
BSc/MSc/ B. Pharmacy / M. Pharmacy
1-2 years experience Preferable
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.