Clinical Research Coordinator B

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Posted Job Title

Clinical Research Coordinator B

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

The Clinical Studies Unit (CSU) within the Department of Dermatology is seeking a highly motivated, organized, and detail-oriented individual to support the fast-paced day-to-day operations of multiple clinical trials, investigator-initiated studies, and translational biobank projects focused on dermatologic diseases. Essential responsibilities include, but are not limited to: screening, recruitment, and enrollment of study participants; data collection, entry, and management in accordance with protocol requirements; scheduling and conducting research visits in clinic; maintaining regulatory files; and preparing submissions to the Penn Biomedical Institutional Review Board (IRB) and central IRBs when applicable.

The individual will work within a highly collaborative research environment alongside a team of study coordinators, a regulatory specialist, project managers, investigators, and clinical staff to advance the dermatology research mission of the Department and University.

We are looking for a professional who thrives in a collaborative, fast-paced environment and is passionate about advancing dermatological research. This role offers an exciting opportunity for career growth, with comprehensive training and development provided to support the CRC in their professional journey from initial onboarding to ongoing career advancement within clinical research.

Position Responsibilities:
• Screen, recruit, consent, and enroll study participants as specified per protocol and GCP guidelines.
• Schedule, prepare for, and conduct participant visits and any necessary testing/specimen collection.
• Obtain, handle, process, and ship biospecimens including blood, urine, and tissue.
• Transport specimens to multiple labs on campus.
• 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.
• Enter data in electronic data capture systems.
• Perform data QC and address queries.
• Show vigilance in participant safety, protocol compliance and data quality.
• Adhere to all University of Pennsylvania, FDA and GCP guidelines.
• Effectively and independently managing multiple trials while also assisting other coordinators as needed.
• Demonstrate leadership skills by identifying challenges and problem-solving emergent issues
• Present and implement strategies for participant recruitment.
• Work closely with the Clinical Research Program Manager on study start-up activities.

Job Description

Job Responsibilities

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