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Clinical Trial Site Coordinator

EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE
Remote: 
Full Remote
Contract: 
Experience: 
Expert & Leadership (>10 years)
Work from: 

Offer summary

Qualifications:

College or university degree in Life Science, Prior experience in coordinating clinical trials, Ability to work in fast-paced environment.

Key responsabilities:

  • Act as main communication line between Sponsor/CRO and site
  • Ensure timely response to feasibility questions
  • Track patient enrollment, support meeting project timelines
  • Accurate data entry into study specific EDC systems
  • Prepare for and participate in onsite audits or inspections
PSI CRO AG  logo
PSI CRO AG Pharmaceuticals Large https://www.psi-cro.com/
1001 - 5000 Employees
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Job description

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Company Description

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.

    Job Description

    The Milestone One Site Coordinator role supports a Clinical Study Site in all trial 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
    • College or university degree in Life Science
    • Prior experience in coordinating clinical trials on site
    • Ability to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously.
    • Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner.
    • Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.

    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.

    Required profile

    Experience

    Level of experience: Expert & Leadership (>10 years)
    Industry :
    Pharmaceuticals
    Spoken language(s):
    Check out the description to know which languages are mandatory.

    Soft Skills

    • Physical Flexibility
    • Problem Solving
    • Time Management
    • Verbal Communication Skills
    • Calmness Under Pressure

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