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:
- Actas the main line of communication between the Sponsor or CRO and the site.
- Ensureresponse to feasibility questions are provided in due time.
- Assistin scheduling and preparation for all types of monitoring visits at the medical institution/research center.
- Be present and available to respond to monitors duringall types of monitoring visits conducted at the medical institution.
- Trackpatient enrollment and actively supportthe medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
- Maintainstudy 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, handleand maintainall site-specific regulatory documents as needed.
- Facilitateand support the contract and budget negotiations at the site level.
- SupportInvestigator and Site payments and processes as needed.
- Scheduleand/or performstudy procedures as per study requirements and delegation of responsibilities.
- Preparefor and participatein onsite study audits or regulatory agency inspections.
- Buildand sustainlong-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).
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:
- Actas the main line of communication between the Sponsor or CRO and the site.
- Ensureresponse to feas