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 :
What are we looking for
- At least 1-2 years experience as a clinical research coordinator
- Current BLS (basic life support) certification or willingness to obtain prior to employment
- Proficient in medical terminology
- Proficient in basic patient assessments (vital signs triage medication reconciliation)
- Phlebotomy certification or willingness to obtain during employment (only applicable if you are Non-Licensed or a Certified Medical Assistant (CMA).
- Proficient in Microsoft Office applications
Desired:
- Urology Experience
- Certification as a clinical research coordinator / professional
- Certified Medical Assistant(CMA) Licensed Practical Nurse (LPN) or Registered Nurse (RN)
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 :
Full-time