Freelance Site Coordinator

PSI CRO; München; Vor Ort; EUR 40.000 - 55.000; Teilzeit

Zusammenfassung

A leading company in clinical study site support is seeking a Site Coordinator to assist with clinical trial activities. This part-time role involves communication with sponsors, tracking patient enrollment, and ensuring compliance with protocols. Ideal candidates will have a degree in Life Science and experience in a similar role. Join a team focused on making a difference in clinical research.

Qualifikationen

• Minimum of 2 years of on-the-job experience as a Site Coordinator.
• Ability to work in a fast-paced environment with multiple tasks.

Aufgaben

• Act as the main line of communication between the Sponsor or CRO and the site.
• Track patient enrollment and support the medical site in meeting project timelines.
• Prepare for and participate in onsite study audits.

Kenntnisse

Communication

Problem-Solving

Ausbildung

University Degree in Life Science

Jobbeschreibung

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 clinical trial-related activities according to ICH-GCP, protocol requirements within study-specific defined timelines and enrollment goals.

This is a part-time assignment for around 0.2 FTE.

1. Act as the main line of communication between the Sponsor or CRO and the site.
2. Ensure responses to feasibility questions are provided in due time.
3. Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center.
4. Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.
5. Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
6. Maintain study-specific and general tracking of documents at the site level.
7. Ensure accurate and timely data entry into study-specific EDC systems and timely resolution of data clarification queries issued for the site.
8. Report and follow up on Reportable Adverse Events and Protocol Deviations in a timely manner.
9. Handle, account for, and reconcile investigational products and clinical supplies properly.
10. Collect, handle, and maintain all site-specific regulatory documents as needed.
11. Facilitate and support contract and budget negotiations at the site level.
12. Support Investigator and Site payments and processes as needed.
13. Schedule and/or perform study procedures as per study requirements and delegation of responsibilities.
14. Prepare for and participate in onsite study audits or regulatory agency inspections.

Qualifications

• A university degree in Life Science, preferably in pharmacy, nursing, or lab analytics.
• Minimum of 2 years of on-the-job experience as a Site Coordinator.
• 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 problem-solving skills effectively and efficiently.
• Valid US Driver's License with the ability to travel as needed.
• Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.

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