Site Coordinator (Freelance).

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The Milestone One Site Coordinator role supports a Clinical Study Site in clinical trial activities according to ICH-GCP and protocol requirements within defined timelines and enrollment goals.

The responsibilities of this role may include, but are not limited to:

1. Act as the main communication link between the Sponsor or CRO and the site.
2. Ensure responses to feasibility questions are provided promptly.
3. Assist in scheduling and preparing for monitoring visits at the medical institution/research center.
4. Be present and available during all monitoring visits conducted at the medical institution.
5. Track patient enrollment and support the site and CRO/Sponsor team in meeting project timelines and enrollment goals.
6. Maintain study-specific and general document tracking at the site level.
7. Enter data accurately and timely into study-specific EDC systems and resolve data clarification queries promptly.
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 inspections.

Qualifications

• A university degree in Life Sciences, preferably in pharmacy, nursing, or lab analytics. An adequate combination of relevant experience, education, and training that demonstrates the necessary knowledge, skills, and abilities may be considered.
• Minimum of 2 years of experience in a clinical trial environment, with relevant experience in clinical trials, terminology, and medical research in a Study Coordinator or similar role.
• Proficiency in French and English.
• Ability to work in a fast-paced environment with tight deadlines and multiple tasks.
• Effective communication skills in stressful situations and problem-solving abilities.
• Valid Driver's License with the ability to travel as needed.
• Flexibility in working hours depending on study schedules and patient visits.