"Clinical Research Coordinator B (Department of Otorhinolaryngology)"

Job Description Summary

The Clinical Research Coordinator B will support research studies focused on obstructive sleep apnea (OSA) and related physiological testing in adult humans. They will coordinate all aspects of study execution, including participant recruitment, study visits, data collection, and regulatory compliance. This role ensures that studies are conducted according to protocol and Good Clinical Practice (GCP) guidelines, facilitates accurate documentation and reporting, and serves as a liaison among participants, investigators, and study sponsors. The coordinator plays a key role in advancing OSA research by ensuring reliable data collection and proper documentation throughout each study.

Job Description

Job Responsibilities

• Clinical Research Coordinator B will be responsible for independently carrying out study procedures with minimal oversight.
• Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility before participation.
• Prepare and process Institutional Review Board (IRB) submissions through the IRB and other regulatory groups as appropriate, including initial submissions, amendments, continuing reviews, adverse events, and serious adverse events.
• Coordinate, organize, and maintain all documentation required by the sponsor or CRO (case report forms, source documentation, study and regulatory binders, and subject binders).
• Assist in the coordination and execution of IDE-regulated clinical trials, including participant management, device handling, regulatory compliance, and study documentation.
• Participate in the conduct of study audits by sponsors, CROs, the FDA, and other entities as required.
• Schedule patient visits and any required testing.
• Adhere to all University of Pennsylvania, Institutional Review Board (IRB), and FDA regulations and guidelines.
• Conduct initiation, monitoring, and closeout visits with sponsors and CROs.

Position is contingent on continued funding. "At this time, we are only able to consider candidates who are authorized to work without the need for visa sponsorship."

Qualifications

• Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Job Location

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$52,500.00 - $55,294.00 Annual Rate