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Job Description

Clinical Research Coordinator

Bombay, Inde R1503449 Field-based

Bombay, Inde| Inde

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Description du poste

Conduct site/trial feasibility to identify & select the right site and investigator for the study Ø  
Ensure timely compilation of all essential documents & assist in regulatory package preparation, timely submission, follow up with site EC to resolve any queries, and obtain approvals Ø  Ensuring site setup according to protocol, review patient data base & pre-screening, identify physician network Ø  Coordinate for Clinical Trial Supplies receipt, accountability & storage Ø  
Prepare site team for study initiation visit and coordinate with monitor for the visit Ø  
Assist in the process of administering the informed consent to the potential objects and discussing in detail the patient information sheet Ø  
Ensure that site documentation remains current, accurate and complete Ø  
Coordinate for lab samples collection and logistics; review of lab reports and update PI Ø  
Review & implement appropriate recruitment/referral activities for active enrolment at sites Ø  
Ensure CRF Completion and query resolution on specified timelines Ø  
Coordinate in conduct of monitoring visits and audits (Internal or External) Ø  
Ensure that monitoring/audit related findings are resolved within the timelines Ø  
Ensure patient follow up visit and visit compliance; manage patient related reimbursement; site related payment Ø  Drug receipt, accountability, storage, dispensing and related documentation Ø  
Ensure adherence to protocol guideline, regulations, ethical guidelines Ø  
Coordinate and ensure timely reporting to all stakeholders Ø Maintain study log(s) & study manuals Ø  
Assist monitor with the site closeout activities Ø  
Manage final reconciliation of Clinical Trial Supplies and archival of study documents at sites

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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