Clinical Research Coordinator II

Evaluating protocol feasibility, including amendments, with respect to logistics and ethical requirements

• Visit Reporting:

Accurately reporting visits and procedures; ensuring proper entry of all participant visits and clinical procedures into the CCS system.

Verifying data prior to financial reconciliation; ensuring additional procedures are documented correctly before submission for payment.

• Study Logistics:
• Verifying availability of study materials and equipment: lab kits, IMP, specialized devices, system access (IVRS/EDC), passwords, and permissions, and providing technical support to investigators.
• Site Operations Support:

Supporting site operations for non-study-specific activities (office work, equipment, resources) as agreed with the supervisor.

Managing assigned equipment responsibly.

Liaising with vendors during the study, coordinating participant visits scheduling, updating patient files with test results, and cooperation in resolving Sponsor queries.

Providing backup support in the absence of the primary CRC.

Creating study schematics in CCS

• PSSV (Pre-Study Site Visit):
• Summarizing required documentation prior to PSV, participating in PSSV (on-site or remote) ; post-visit reporting and documentation preparation remain CRC responsibilities.
• Additional Technical Support:
• Setting up email accounts and providing IT support for investigators; preparing initial CVs.
• Performing any other tasks as assigned by the supervisor.
• The above responsibilities are not exhaustive and may be expanded, reduced, or reassigned based on business needs and current circumstances