Clinical Research Coordinator

0 years

0 Lacs

Posted:6 hours ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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 ØPrepare site team for study initiation visit and coordinate with monitor for the visit ØAssist in the process of administering the informed consent to the potential objects and discussing in detail the patient information sheet ØEnsure that site documentation remains current, accurate and complete ØCoordinate for lab samples collection and logistics; review of lab reports and update PI ØReview & implement appropriate recruitment/referral activities for active enrolment at sites ØEnsure CRF Completion and query resolution on specified timelines ØCoordinate in conduct of monitoring visits and audits (Internal or External) ØEnsure that monitoring/audit related findings are resolved within the timelines ØEnsure patient follow up visit and visit compliance; manage patient related reimbursement; site related payment Ø Drug receipt, accountability, storage, dispensing and related documentation ØEnsure adherence to protocol guideline, regulations, ethical guidelines ØCoordinate and ensure timely reporting to all stakeholders Ø Maintain study log(s) & study manuals ØAssist monitor with the site closeout activities ØManage final reconciliation of Clinical Trial Supplies and archival of study documents at sitesIQVIA 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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IQVIA

Pharmaceuticals / Biotechnology

Durham

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