Clinical Research Coordinator

Iqvia Biotech

1 - 3 years

3 - 7 Lacs

mumbai

Posted:23 hours ago| Platform:

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Skills Required

clinical operations medical writing pharmaceutical ich-gcp guidelines clinical data management pharmacovigilance icf research healthcare drug cra clinical research recruitment crc crf site initiation ich-gcp life sciences clinical trials schedule y

Work Mode

Work from Office

Job Type

Full Time

Job Description

Conduct site/trial feasibility to identify and select the right sites and investigators for studies.
Ensure timely compilation of all essential documents and assist in regulatory package preparation.
Coordinate with sites for study initiation, review patient data base, pre-screening, and identify physician networks.
Manage clinical trial supplies receipt, accountability, storage, dispensing, and related documentation.
Prepare site teams for study initiation visits and coordinate with monitors for these visits.
Assist in administering informed consent and discussing patient information sheets with potential objects.
Maintain current, accurate, and complete site documentation.
Coordinate lab sample collection and logistics, review lab reports, and update principal investigators; review and implement recruitment/referral activities for active enrolment at sites.
Ensure CRF completion and query resolution on specified timelines, and coordinate monitoring visits and audits (internal or external).
Resolve monitoring/audit findings within timelines, ensure patient follow-up visit compliance, manage patient reimbursement, and handle site-related payments.
Maintain study logs and study manuals, and assist monitors with site close-out activities.
Manage final reconciliation of clinical trial supplies and archive study documents at sites.

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