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:
- 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.
- College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
- 2-3 years of site coordinating experience is required
- Ability to multitask across various protocols
- English - Spanish bilingual
- Ability to work on Saturdays
- Experience with eSource systems (preferred)
- Experience in cardiometabolic and/or GI trials
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.
