Clinical Trial Site Coordinator

Milestone One

Clinical Trial Site Coordinator

Harlingen, TX
Full Time
Paid
  • Responsibilities

    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:

    • 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.
  • Qualifications

    Qualifications

    • College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
    • 2-3 years of site coordinating experience is required
    • Ability to multitask across various protocols
    • English - Spanish bilingual
    • Ability to work on Saturdays
    • Experience with eSource systems (preferred)
    • Experience in cardiometabolic and/or GI trials

    Additional Information

    If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you.