Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India.
Post : Clinical Research Associate- BEC
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
Experience : 1-2 years
Qualification : MSc, M.Pharma, BSc, B.Pharm
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
End Date : 25th October, 2020
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