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.
The function of the role may include, but not limited to, any/all of the following:
- 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.
- Completed vocational training as a nurse ("Gesundheits- und Krankenpfleger/in" or "Pflegefachfrau/Pflegefachmann") or Medical Assistant ("MFA" = "Medizinische Fachangestellte"), or completed degree in a relevant field (e.g. health sciences, biology, pharmacy, public health)
- 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 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.
- Valid IATA and GCP Certification
- Fluent English and German
It's a hybrid part time position 0.75 FTE. 30h per week. 20h On site, 10h remotely.
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.
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.