Clinical Research Coordinator B/C

Job Description Summary

The Clinical Studies Unit (CSU) within the Department of Dermatology is seeking a highly motivated, organized, and detail-oriented Clinical Research Coordinator to support the fast-paced day-to-day operations of multiple investigator-initiated and industry-sponsored clinical trials focused on dermatologic diseases.

Job Responsibilities

Clinical Research Coordinator B

• Screen, recruit, consent, and enroll study participants as specified per protocol and GCP guidelines.
• Schedule, prepare for, and conduct protocol-required participant visits and assessments.
• Review clinic schedules and medical records to identify potentially eligible participants and support recruitment efforts.
• Prepare and submit IRB documentation for initial submissions, continuing reviews, amendments, and adverse event reporting.
• Coordinate, organize, complete, and maintain source documents, case report forms, regulatory documents, and participant binders in accordance with ALCOA-C standards.
• Enter data into electronic data capture systems (e.g., REDCap, sponsor systems) and ensure data accuracy and completeness.
• Perform data quality control and resolve data queries within required timelines.
• Monitor participants per protocol requirements and document adverse events and protocol deviations as applicable.
• Demonstrate vigilance in participant safety, protocol compliance, and data quality.
• Adhere to all University of Pennsylvania policies and applicable FDA and GCP guidelines.
• Effectively manage multiple clinical trials independently while supporting other coordinators as needed.
• Demonstrate problem-solving skills by identifying challenges and escalating issues appropriately.
• Develop, present, and implement participant recruitment strategies in collaboration with investigators and the research team.
• Work closely with the Clinical Research Program Manager to support study start-up, activation, and ongoing trial operations.

Clinical Research Coordinator C

(In addition to the responsibilities outlined for CRC-B)

• Work independently with minimal supervision and may serve in a lead coordinator role or act as back-up to the supervisor.
• Independently coordinate complex investigator-initiated and industry-sponsored dermatology clinical trials, managing study timelines, workflows, and day-to-day execution.
• Partner directly with faculty investigators to support study design, start-up, and implementation of investigator-initiated trials.
• Provide guidance, training, or informal mentorship to less experienced coordinators and support coverage during staffing transitions.
• Contribute to preparation of study reports, abstracts, manuscripts, or grant applications as requested by investigators.
• Support budget-related activities and study feasibility discussions in collaboration with CSU leadership, as appropriate.