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.
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.
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 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
Additional Information
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.