Clinical Research Coordinator

Iqvia Biotech

0 - 5 years

2 - 7 Lacs

mumbai

Posted:23 hours ago| Platform:

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Skills Required

query resolution clinical research coordinator reconciliation database clinical research healthcare life sciences recruitment auditing logistics

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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