Clinical Trial Site Coordinator
Clinical Trial Site Coordinator
Posted on :
20-12-2024
Employer Active
1 Vacancy
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Job Description
Milestone One Site Coordinator supports trial sites in all related activities according to ICHGCP 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 sitespecific 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 :
- 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 fastpaced environment with short timelines and multiple tasks to be completed simultaneously.
- Ability to effectively communicate in stressful situations and demonstrate the ability to problemsolve in an effective and efficient manner.
- Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
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