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Clinical Site Coordinator

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

The ideal candidate will possess:A university degree in Life Sciences, preferably in pharmacy, nursing, or laboratory analytics. A minimum of 2 years' experience as a site coordinator in clinical trials. The ability to thrive in a fast-paced environment, managing multiple tasks and meeting tight deadlines. Strong communication skills, particularly in high-pressure situations, coupled with effective problem-solving abilities. Flexibility in working hours as required by study procedures and patient visits. Fluency in English and the local language.

About the job

The Clinical Site Coordinator at Milestone One plays a vital role in facilitating clinical trial activities at study sites, adhering to ICH-GCP guidelines and ensuring compliance with study protocols within defined timelines and enrollment targets.

Key responsibilities include:

  • Serving as the primary communication link between the Sponsor/CRO and the clinical site.
  • Providing timely responses to feasibility inquiries.
  • Assisting in the scheduling and preparation for various monitoring visits at the research facility.
  • Being present during monitoring visits to address queries from monitors.
  • Monitoring patient enrollment and actively collaborating with the site and CRO/Sponsor to achieve project timelines and enrollment goals.
  • Maintaining meticulous tracking of study-specific and general documents at the site level.
  • Ensuring accurate and timely data entry into electronic data capture systems, along with prompt resolution of data clarification requests.
  • Reporting and following up on Reportable Adverse Events and Protocol Deviations without delay.
  • Managing the handling and reconciliation of investigational products and clinical supplies.
  • Collecting and maintaining all site-specific regulatory documents as necessary.
  • Facilitating contract and budget negotiations at the site level.
  • Supporting Investigator and Site payments and processes as required.
  • Scheduling and/or executing study procedures as per study requirements and delegated responsibilities.
  • Preparing for and participating in onsite audits or inspections by regulatory agencies.

About Milestone One

Milestone One is a leading Site Enabling Services organization headquartered in Zug, Switzerland. Our mission is to empower clinical study sites by providing the necessary support for effective study delivery and enhanced outcomes.

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