Apotex Research Pvt. Ltd. is a wholly owned subsidiary of Apotex Inc. Canada which is a number one generic pharma co. in Canada. The position is for Bangalore location which has an R&D Centre, Manufacturing and a Bioequivalence Centre.
Post: Study Co-ordinator
Responsible for protocol management, study documentation, protocol training to the staff and ensures project logistics.
• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
• Prepares/Reviews protocol prior to IRB review for correctness, compliance, subject safety and feasibility of study design
• Coordinates protocol review process with all applicable reviewers and makes updates to protocol as required
• Responsible for all activities related to the protocol management including the coordination of the Informed consent translations, protocol status reports, preparing protocols for IRB meetings
• Ensures all regulatory documents are completed for the applicable jurisdictions
• Responsible for general inquiries from volunteer/subjects
• Activates approved Protocol for study use and distribution after IRB approval and applicable sign off
• Prepares screening and study documentation for data collection
• Ensures that recruitment targets meet protocol study requirements
• Coordinates with booking volunteers for registration, screening activities and follow-up appointments as required
• Reviews the completed Screening documentation for inclusion and exclusion criteria dictated by project-specific protocols.
• Conducts protocol training with all staff involved in the screening/study activities.
• Ensures adequate quantity of materials and supplies are available before initiation of the study.
• Oversees in the TA license procedure, receipt, dispensation and inventory of test materials
• Log out of test articles and assigns applicable Nurse/Staff to distribute to subjects
• Directly supervises and takes delegated responsibility for the conduct and safety of volunteers participating in clinic trials, for adherence to protocols and regulatory requirements
• Monitors clinic staff activities for compliance with protocol and SOPs
• Collects, reviews and summarizes clinical data, reports, and compiles the clinical portion of the report
• Oversees the sample transfer process
• Ensures projects meet the projected timelines and communicates updates
• Assists in the creation, development and revision of the Bioequivalence Centre’s Clinical Operations Department Standard Operating Procedures.
• Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
• M. Pharmacy or B. Pharmacy required
• 2-7 years experience Preferable
Experience: 2-7 year
Education: M.Pharm, B.Pharm
Industry Type: Pharma/biotech/Clinical research
Functional Area: CR
Apply/Send resume at, firstname.lastname@example.org
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