Apotex Inc., founded in 1974, is the largest Canadian-owned pharmaceutical company. We employ over 6,000 people worldwide in research, development, manufacturing and distribution. We produce more than 300 generic pharmaceuticals in approximately 4000 dosages and formats and export to over 115 countries around the globe.
Job Title – Clinical Research Associate (ba-be Studies)
Openings – 05
Experience – 2 – 5 yrs
Location – Bangalore/Bengaluru
Salary – INR 3,50,000 – 6,00,000 P.A.
Job Requirements/ Education/ Competencies:
1. Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centers Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
2. Assists with Protocol, ICF writing, Case Report and Assists with the preparation of screening and study documentation for data collection
3. Assists with follow-up appointments of Subjects
4. Assists as required in the receipt, dispensation and inventory of test articles
5. Prepares the clinic for study conduct ensuring all furniture, supplies and equipment ready for screening/clinic activities
6. Ensures clinic staff activities for compliance with protocol and SOPs
7. Assists with the Collection, reviewing and summarizing of clinical data and compilation of the clinical report
8. Assist with the distribution of test articles to subjects as delegated by the Study Coordinator
9. Conducts activities related to the transfer of subject samples
10. Responsible for initiation and completion of archival of clinic study raw data, documents and records.
11. Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow
1. Master Degree in Pharmacy/Master Degree in Science. Specialization in Clinical Pharmacology/Clinical Research is desirable.
2. He / She should have minimum of 2 to 5 years of experience in Clinical Research, experience in BABE studies is a must.
2. Works as a member of a team to achieve all outcomes.
2. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
3. Performs all work in accordance with all established regulatory and compliance and safety requirements.
4. All other duties as assigned.
- UG:B.Sc – Any Specialization, B.Pharma – Pharmacy
- PG:MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy