Freelance Clinical Trial Site Coordinator

PSI CRO; Köln; Vor Ort; EUR 40.000 - 70.000; Vollzeit

Zusammenfassung

Join a forward-thinking company as a Site Coordinator, where you will play a vital role in supporting clinical trial sites. This position involves acting as the primary communication link between sponsors and sites, ensuring compliance with study protocols, and tracking patient enrollment. You'll thrive in a fast-paced environment, handling multiple tasks while maintaining high standards of data accuracy and regulatory compliance. If you're ready to showcase your skills in a dynamic setting focused on people and growth, this opportunity is perfect for you.

Qualifikationen

• Degree in Life Science required, preferably in pharmacy, nursing, or lab analytics.
• Prior experience in coordinating clinical trials on site is essential.

Aufgaben

• Act as the main communication line between Sponsor/CRO and the site.
• Track patient enrollment and support the medical site in meeting goals.
• Ensure accurate and timely data entry into study-specific systems.

Kenntnisse

Clinical Trial Coordination

Effective Communication

Problem-Solving

Data Entry

Regulatory Compliance

Ausbildung

Degree in Life Science

Pharmacy, Nursing or Lab Analytics

Tools

EDC Systems

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

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:

1. Act as the main line of communication between the Sponsor or CRO and the site.
2. Ensure response 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. Accurate and timely data entry into study-specific EDC systems and timely resolution of data clarification queries issued for the site.
8. Timely reporting and follow-up on Reportable Adverse Events and Protocol Deviations.
9. Proper handling, accountability, and reconciliation of investigational products and clinical supplies.
10. Collect, handle and maintain all site-specific regulatory documents as needed.
11. Facilitate and support the 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

1. College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
2. Prior experience in coordinating clinical trials on site.
3. Ability to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously.
4. Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner.
5. 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 true focus on its people, then Milestone One is the right choice for you.