Freelance Clinical Trial Site Coordinator

Job Description

Milestone One Site Coordinator supports trial sites in all related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.

In this role you will :

• Act as the main line of communication between the Sponsor or CRO and the site.
• Ensure response to feasibility questions are provided in due time.
• Assist in scheduling and preparation for all types of monitoring visits at the medical institution / research center.
• Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.
• Track patient enrollment and actively support the medical site and CRO / Sponsor team in meeting project timelines and enrollment goals.
• Maintain study specific and general tracking of documents at the site level.
• Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.
• Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations.
• Proper handling, accountability and reconciliation of investigational products and clinical supplies.
• Collect, handle and maintain all site-specific regulatory documents as needed.
• Facilitate and support the contract and budget negotiations at the site level.
• Support Investigator and Site payments and processes as needed.
• Schedule and / or perform study procedures as per study requirements and delegation of responsibilities.
• Prepare for and participate in onsite study audits or regulatory agency inspections.

Qualifications

Additional Information

If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you.