Lead Site Coordinator

1 неделя назад

Almaty, Almaty, Казахстан PSI CRO Полный рабочий день 900 000 ₸ - 1 200 000 ₸ в год

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.
  • Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).

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