Freelance Site Coordinator
Freelance Site Coordinator
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Salary Not Disclosed
1 Vacancy
Job Description
The Milestone One Site Coordinator role supports a Clinical Study Site in clinical trial related activities according to ICHGCP protocol requirements within Study specific defined timelines and enrollment goals.
This is a 1 year term with variable hours up to 40/week.
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 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 :
- A university degree in Life Science preferably in pharmacy nursing or lab analytics.
- An adequate combination of relevant on the job experience education and training that confirms the availability of the knowledge experience skills and abilities required for the position may be considered.
- Minimum of 2 years of onthejob experience in a clinical trial environment where relevant experience has been gained in clinical trials clinical terminology and medical research working in the role of a Study Coordinator or similar function.
- 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.
- Valid US Drivers License with the ability to travel as needed.
- 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
