Clinical Research Coordinator B/C

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Job Title: Clinical Research Coordinator B/C

Job Profile Title: Clinical Research Coordinator B

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 Description Summary

The primary function of this position is to facilitate, promote, and ensure the conduct of high-quality clinical research in accordance with Good Clinical Practice (GCP), institutional policies, and regulatory requirements.

Essential Responsibilities

• Screening, recruitment, consent, and enrollment of study participants
• Coordination of protocol-required visits and assessments
• Accurate data collection, entry, and management
• Maintenance of regulatory and study documentation
• Preparation and submission of materials to the Penn Biomedical Institutional Review Board (IRB) and central IRBs, as applicable

Additional Responsibilities

• Supporting all phases of clinical trial execution, including study start-up, ongoing study conduct, monitoring, and close-out activities
• Working within a highly collaborative research environment alongside study coordinators, a regulatory specialist, project managers, investigators, and clinical staff to advance the dermatology research mission of the Department and the University
• Independent coordination of assigned studies, direct communication with investigators, sponsors, and CROs, and a strong commitment to participant safety, protocol compliance, and data quality

Requirements

• 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
• Bachelor's degree and 2-3 years of experience, or equivalent combination of education and experience, are required

Clinical Research Coordinator C

In addition to the responsibilities outlined for CRC-B, the Clinical Research Coordinator C will:

• 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

Responsibilities/Duties

• Lead participant screening by reviewing medical records and assessing eligibility criteria
• Conduct informed consent discussions, ensure participant understanding, and maintain required documentation
• Support recruitment through clinic schedule review, coordination with investigators and 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
• Monitor participants per protocol requirements, document adverse events and concomitant medications, and complete safety reporting in a timely and accurate manner
• Prepare study start-up materials, including visit guides, source documentation tools, participant binders, e-regulatory binders, and required tracking logs
• Review clinical information from visits and assessments and enter required data into electronic data capture platforms with a focus on accuracy and completeness
• Maintain organized source documentation, regulatory files, and enrollment logs to support monitoring, audit, and internal review
• Participate in study meetings, initiation sessions, and protocol training
• Provide regular updates on enrollment progress, visit completion, safety reporting, and data status
• Support operational consistency by identifying workflow needs and contributing to tools, guidance documents, or process improvements that enhance study execution

Qualifications

• 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
• Bachelor's degree and 4-5 years of experience, or equivalent combination of education and experience, are required

Salary and Benefits

• Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level
• Internal organization and peer data at Penn are also considered
• University Benefits:
• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare
• Tuition: Take advantage of Penn's exceptional tuition benefits
• Retirement: Penn offers generous retirement plans to help you save for your future
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility
• Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities
• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household