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