About the job
The Clinical Site Coordinator at Milestone One plays a pivotal role in supporting our Clinical Study Site during various clinical trial activities. This position requires adherence to ICH-GCP guidelines and adherence to protocol requirements, all while working within specific timelines and enrollment targets.
The responsibilities of the Clinical Site Coordinator include, but are not limited to:
- Serving as the primary communication liaison between the Sponsor or CRO and the clinical site.
- Timely provision of responses to feasibility queries.
- Assisting in the scheduling and preparation for all monitoring visits at the medical institution/research center.
- Being accessible to monitors during monitoring visits at the medical site.
- Tracking patient enrollment and actively assisting both the medical site and CRO/Sponsor teams in achieving project deadlines and enrollment objectives.
- Maintaining both study-specific and general document tracking at the site level.
- Ensuring accurate and prompt data entry into study-specific electronic data capture (EDC) systems, with timely resolution of any data clarification queries.
- Reporting and following up on Reportable Adverse Events and Protocol Deviations in a timely manner.
- Responsible management, accountability, and reconciliation of investigational products and clinical supplies.
- Collecting, handling, and maintaining all site-specific regulatory documents as required.
- Facilitating and aiding in contract and budget negotiations at the site level.
- Supporting investigator and site payment processes as needed.
- Scheduling and/or performing study procedures as per study requirements and delegated responsibilities.
- Preparing for and participating in onsite study audits or regulatory agency inspections.