About the job
As a Clinical Site Coordinator at Milestone One, you will play a pivotal role in facilitating clinical trial activities at a study site, ensuring compliance with ICH-GCP guidelines and specific protocol requirements. Your responsibilities will include:
- Serving as the primary communication link between the Sponsor or CRO and the clinical site.
- Promptly addressing feasibility inquiries and providing necessary information.
- Coordinating and preparing for various types of monitoring visits at the research center.
- Being available and responsive to monitors during site visits.
- Monitoring patient enrollment and collaborating with the medical site and CRO/Sponsor team to meet project milestones.
- Maintaining organized tracking of study-specific and general documents at the site level.
- Conducting accurate data entry into study-specific EDC systems and resolving data clarification queries in a timely manner.
- Reporting and following up on Reportable Adverse Events and Protocol Deviations promptly.
- Managing the accountability and reconciliation of investigational products and clinical supplies.
- Collecting and maintaining all site-specific regulatory documents as required.
- Assisting with contract and budget negotiations at the site level.
- Supporting Investigator and Site payment processes as necessary.
- Scheduling and/or performing study procedures as per study requirements.
- Preparing for and participating in onsite study audits or regulatory agency inspections.