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:
- Actas the main line of communication between the Sponsor or CRO and the site.
- Ensureresponse to feasibility questions are provided in due time.
- Assistin scheduling and preparation for all types of monitoring visits at the medical institution/research center.
- Be present and available to respond to monitors duringall types of monitoring visits conducted at the medical institution.
- Trackpatient enrollment and actively supportthe medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
- Maintainstudy 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, handleand maintainall site-specific regulatory documents as needed.
- Facilitateand support the contract and budget negotiations at the site level.
- SupportInvestigator and Site payments and processes as needed.
- Scheduleand/or performstudy procedures as per study requirements and delegation of responsibilities.
- Preparefor and participatein onsite study audits or regulatory agency inspections.
Qualifications
- College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
- Prior experience in coordinating clinical trials on site
- 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.
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.
