"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 Responsibilities

• Lead participant screening by reviewing medical records, assessing eligibility criteria, and confirming qualification before enrollment. Conduct informed consent discussions, ensure participant understanding, and maintain appropriate documentation. Support recruitment through clinic schedule review, coordination with referring providers, and direct outreach to potential participants.
• Coordinate all protocol-required visits, treatments, assessments, and follow-up appointments to ensure adherence to study timelines and procedures. Meet with the Principal Investigator to review subject status, assess required next steps, and address questions related to assessments, documentation, or clinical issues. Identify operational barriers and escalate items requiring medical or regulatory decision-making.
• Coordinate investigational product or device administration by securing provider orders, confirming product details, and ensuring proper timing and visit workflow. Monitor subjects for expected or unexpected reactions, document findings, and complete safety reporting in a timely and accurate manner. Report adverse events to the sponsor, IRB, and designated oversight groups according to study requirements.
• Prepare study start-up materials, including visit guides, source documentation tools, subject binders, e-regulatory binders and required tracking logs. Assemble and submit documents to institutional committees for study activation (e.g., IRB, CTSRMC), ensuring alignment with institutional requirements and study timelines. Confirm workflow feasibility with clinic operations and ensure appropriate readiness before first enrollment.
• Review clinical information from visits, labs, and procedures and enter required data into study case report forms or electronic platforms with a focus on accuracy and completeness. Maintain organized subject records, source notes, regulatory files, and enrollment logs to support monitoring, audit, and internal review. Ensure data entry, document updates, and outstanding queries are addressed within study timeframes.
• Participate in ongoing study meetings, initiation sessions, and protocol training. Provide regular updates on enrollment progress, visit completion, investigational product administration, and data status. Support operational consistency by identifying workflow needs and contributing to tools, guidance documents, or process refinements that improve coordinator performance and study execution.
• Other duties and responsibilities as assigned.

Qualifications

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

Effective problem-solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task, demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.

This position is contingent upon funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$52,500.00 - $55,000.00 Annual Rate