تم وضع المناقشة في: غيرها في كاليفورنيا | علق: |
Job Description
The Milestone One Site Coordinator role supports a Clinical Study Site in clinical trial related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.
The function of the role may include, but not limited to, any/all of the following:
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.