Clinical Research Coordinator - Midvalley Dermatology
Job Summary
Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Implement processes and organize efforts within study team to achieve objectives, coordinating research procedures, study visits, and follow-up care.
This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work.
Responsibilities
- Create and maintain tools and documentation to track study metrics, providing updates to management.
- Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities.
- Maintain source documents and report adverse events.
- Recruit, screen, enroll, and obtain consent from study participants.
- Collect and maintain patient and laboratory data.
- Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies. Works under the direction of the Primary Investigator (PI).
- Attain and retain Clinical Research Coordinator Certification (CCRC).
- Understand the process of preparing, submitting, and maintaining IRB, FDA, and/or other regulatory documents and research correspondence.
- Prepares regulatory documents, including consent forms for submission to research review committees.
- Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
- Tracks study approvals and expirations to ensure uninterrupted project approval.
- Tracks sponsor and investigator initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB).
- Submits study renewal applications and study progress reports to the IRB.
- Coordinates with study sponsor, investigator and IRB to complete study closure activities.
9. Complete time budget assessments and designate study charges vs. standard of care on clinical trials.
10. Maintains regulatory database
11. Mentors and trains new research staff.
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