Clinical Research Associate jobs in Kalambe Turf Thane (Kolhapur) - Biosphere Clinical Research Pvt LTD

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Job Description

•Expert knowledge of ICH-GCP, Schedule Y and applicable regulatory requirements and ability to train others on guidelines applicable for Clinical Operations.

•Conduction of qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.

•Communication with the medical site staff including coordinators, clinical research physicians and their site staff.

•Verifying adequate Investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.

•Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.

•Verification that the Investigator is enrolling only eligible subjects as per study requirements.

•Ability to assess completeness/accuracy and maintenance of regulatory documents in-house (CSF) /on-site (ISF).

•Ensure that the IMP is stored under appropriate protocol specified conditions and accountability is maintained in-house and at the site.

•Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol and applicable regulatory requirements.

•Identify issues in the project proactively and propose resolution and demonstrate ability to assess and problem solve with assistance and escalates issues when appropriate.

•Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement.

•Flexible to take up add-on responsibilities & deliver satisfactorily all the tasks assigned by respective line manager / PM/ Head of Organization in order to support the project deliverables &/or department improvisation.

•Completion of monitoring reports.

Key Skills

Industry

Pharma/BioTech/Clinical Research

Functional Area

Pharma / R&D / Biotech

Number of Vacancy

1

Education

B.Pharma, M.Pharma


About Biosphere Clinical Research Pvt LTD

With facilities in Mumbai, Biosphere Clinical Research Pvt. Ltd. is a venture founded by top-level industry professionals. The bouquet of high-quality services delivered by Biosphere includes Clinical Operations, Remote Monitoring, IWRS (e-Prudent), Data Management, Statistical Analysis, Regulatory Affairs, Medical Writing, PharmacoVigilance and Quality Assurance.

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