Clinical Research Assoc I

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

• To monitor and perform Quality Check of all study activities from check-in, dosing, sample collection, processing, segregation, transfer and till checkout.
• Co-ordinate with Project management Group (PMG) for compliance with the sponsor requirements and timelines.
• Provide periodic review on status of study files up to archival of files.
• Co-ordinate with Report Writing Group for the movement of files to the concerned department and ensuring to maintain timelines.
• Compilation of study data and review of clinical reports.
• Coordinate with the Ethics Committee for submission of protocol and other study related documents.
• To perform QC of ICF, compensation chart and review of CRF (versus Protocol), other study related documents prior to EC submission.
• To ensure that all the activities are performed by the delegated staff personnel in compliance with the EC approved protocol, GCP and relevant SOP’s and applicable regulatory requirement.
• Handling of monitor’s visits, maintaining of site visit log, resolution of all queries raised by the monitor/sponsor during his/ her site visit.
• To carry out other responsibilities as and when assigned by the management.
• Retrospective review of study documents to ensure adherence to required SOPs and regulatory requirements.
• To ensure all appropriate entries after documentation.
• Any discrepencies/ Deviations to be informed to Team Leader and Manager (if Required).
• Ensuring quality by reviewing all study related documents like Regulatory binder, Raw data binders, Case Report Form binders, Study close out report, Sample Case record form, Study updates, screening examination record.
• Full participation in internal and external audits by sponsors and other oversight entities such as FDA, EU, ANVISA.
• Review of SDTM & Clinic tables data with the source document.
• To verify the calibration and verification of instruments/equipment.
• To review the execution of Qualification Protocol & Qualification Summary Report
• To prepare & review standard operating procedures as delegated by PI or HOD or Manager.
• Ensuring quality by reviewing all study related documents like Study Protocol and amendments, Informed consent form, Clinical Study Report, Electronic Trial master file, Study synopsis.
• Providing compliance for reviewed all study related documents like Study Protocol and amendments, Informed consent form, Clinical Study Report, Electronic Trial master file, Study synopsis.
• Review clinical study report to ensure that the reports are in accordance with SOPs, protocol and applicable regulatory requirements, and that the reported results accurately reflect source data of the clinical studies.
• To coordinate with the user department and medical writing department for clinical study reports.

• B.Pharm, M.Pharm, M.Sc 
• 2 -4 Years of experience into QC or Clinical research coordinator (CRC) or Nursing department in Clinical

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