Senior Clinical Trial Site Start-Up Lead

Ftarg Fortrea Argentina S.A.

Ciudad de Mendoza

Sur place

ARS 145 000 - 201 000

Plein temps

Il y a 3 jours
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Résumé du poste

Ftarg Fortrea Argentina S.A. is seeking a Milestone One Site Coordinator to support trial sites under ICH-GCP guidelines. You will act as the primary liaison between Sponsor/CRO and the site, ensure timely feasibility responses, and assist in monitoring visits and data handling.

You will track patient enrollment, maintain site documentation, support contracts and payments, and participate in audits as needed, contributing to smooth study conduct across multiple sites in Argentina.

Qualifications

  • College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
  • Minimum of 3 years of on-the-job experience in a clinical trial environment, where relevant experience has been gained in clinical trials, clinical terminology, and medical research working in the role of a Study Coordinator or similar function.

Responsabilités

  • 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 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).

Connaissances

English (Upper-Intermediate)

Formation

Life Science degree (pharmacy/nursing/lab analytics)

Description du poste

Ftarg Fortrea Argentina S.A. is seeking a Milestone One Site Coordinator to support trial sites under ICH-GCP guidelines. You will act as the primary liaison between Sponsor/CRO and the site, ensure timely feasibility responses, and assist in monitoring visits and data handling.

You will track patient enrollment, maintain site documentation, support contracts and payments, and participate in audits as needed, contributing to smooth study conduct across multiple sites in Argentina.

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