Clinical Research Coordinator II – Mid‑level
umiami · FL
Job description
About the role
The Surgery department at the University of Miami seeks a Clinical Research Coordinator II to support the planning, execution, and oversight of moderate‑risk clinical studies. This mid‑level position manages day‑to‑day protocol activities from initiation through close‑out, ensuring participant safety and regulatory compliance.
Key responsibilities
- Assist with participant recruitment, screening, and retention.
- Perform study procedures, collect data, and manage routine tests.
- Process, pack, and ship biological specimens according to protocol and regulations.
- Maintain study binders, filings, and documentation in line with university policies.
- Distribute study drug materials under the Principal Investigator’s delegation.
- Monitor, document, and report adverse events and protocol deviations.
- Support protocol amendments and study orientation sessions.
- Track study progress, prepare progress reports, and keep investigators informed.
- Facilitate communication with sponsors, data coordinating centers, and compliance monitors.
- Handle administrative tasks for study personnel, including orientation and certification tracking.
Required profile
- Mid‑level experience in clinical research coordination.
- Familiarity with regulatory and sponsor guidelines for human subjects research.
- Ability to work collaboratively with investigators, staff, and external partners.
- Attention to detail in documentation and specimen handling.
Required skills
What we offer
- Opportunity to work in a leading academic surgery department.
- Access to cutting‑edge clinical research projects.
- Professional development and training resources.
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umiami
FL
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