Clinical Trial Coordinator II - FSP

Overview

Clinical Trial Coordinator II (FSP) provides administrative and technical support for clinical trial project teams, including audit readiness and site activation support.

What you'll do

• Coordinate, oversee, and complete functions on assigned trial(s) activities as per the task matrix.
• Perform department, internal, country, and investigator file reviews and document findings in required systems.
• Ensure assigned tasks are completed on time, within budget, and to quality standards; communicate risks to leads and line manager.
• Handle administrative tasks such as (e)TMF document processing, (e)TMF reviews, and distributing communications/documents.
• Review and track local regulatory documents; analyze and reconcile study metrics and findings reports.
• Maintain vendor trackers and support compilation/distribution of Investigator Site File (ISF) and pharmacy binder materials.
• Maintain accurate trial status information in the database and keep (e)TMF up to date using review schedules.

What you'll need

• Comparable experience of at least 2 years as a CTC (CTC role experience required).
• Must have experience in Veeva eTMF and CTMS.
• Should have worked in global clinical trial and coordinated with local/global team members.
• Preferred experience includes vendor management.
• Bachelor’s degree preferred.
• Proficient in MS Office (Word, Excel, PowerPoint) and able to learn clinical trial database systems.
• Ability to understand applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

Details

• Location: Remote, India.
• Work schedule: Mon-Fri (standard).
• Working environment: office/lab/clinical and/or home office.
• Travel: occasional drives to site locations and potential occasional travel.