"Clinical Research Coordinator A"

Job Description

The Department of Dermatology is seeking a highly motivated and detail-oriented Clinical Research Coordinator (CRC) to support patient-oriented clinical and translational research projects within the Clinical Studies Unit (CSU). The CRC will coordinate and implement investigator-initiated, industry-sponsored, and translational studies (Phase II–IV) across a diverse portfolio of dermatology research. This full-time position offers the opportunity to collaborate with faculty investigators, research nurses, and other coordinators in a dynamic academic research environment.

This individual will work under general supervision and will:

• Coordinate and manage patient-oriented studies in accordance with study protocols, ICH-GCP, federal regulations, and University of Pennsylvania policies.
• Recruit and screen participants, conduct eligibility reviews, obtain informed consent, and enroll subjects.
• Schedule and oversee study visits, ensuring timely completion of required assessments (e.g., vitals, ECGs, phlebotomy, questionnaires).
• Collect, process, track, and document biospecimens; maintain inventory in the departmental biobank and Penn Medicine biorepository systems.
• Administer study questionnaires and collect survey data.
• Maintain accurate source documentation, study files and data entry in REDCap and other databases; support monitoring and audit activities.
• Collaborate with investigators and staff; contribute to team meetings.

Job Responsibilities/Duties

• Coordinate biobanking activities: Responsibilities include scheduling and tracking specimen collections, notifying stakeholders (investigators, clinical teams, labs) of required procedures, processing, maintaining biobank inventory systems, and coordinating transfers to internal laboratories. Ensure complete documentation, chain-of-custody, and compliance with biosafety, IRB, and institutional requirements.
• Coordinate the conduct of patient-oriented research and translational biospecimen collection studies within the CSU: Responsibilities include organizing and assisting with documents needed for study initiation, monitoring, audits, and study close-out visits. Complete required initial training (e.g., electronic databases, specimen processing/shipping) and participate in protocol-specific training as needed.
• Recruitment and informed consent: Assist in participant recruitment, including review of medical records of upcoming clinic visits, discussion with investigators and research team, outreach to referring physicians, and pre-screening eligibility calls. Approach potential participants in clinic or by phone. Conduct and document informed consent with participants and families in accordance with IRB and institutional requirements.
• Schedule and coordinate study visits and protocol-required assessments: Schedule participant visits within protocol-defined windows and ensure timely completion of required procedures (e.g., vitals, ECGs, phlebotomy, questionnaires/surveys). Document adverse events and changes in concomitant medications in accordance with protocol and institutional requirements, ensuring timely review and appropriate follow-up by investigators. Assist with investigational product accountability for certain studies if needed.
• Manage study documentation and data entry: Participate in the development and maintenance of study-specific case report forms (e.g., REDCap) and source documents. Maintain all required sponsor/CRO documentation per GCP, including e-regulatory binders, participant binders, and study charts.
• Other duties and responsibilities as assigned.

Qualifications

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required. The successful candidate must have: Strong organizational and communication skills, with attention to detail and data quality. Comfort with direct patient interaction, biospecimen handling, and basic clinical procedures (e.g., vitals, ECGs). Effective problem-solving skills. Effective verbal and written communication skills. Ability to learn new methods quickly and multi-task. Ability to work flexible hours. This position is contingent upon funding. Knowledge of IRB and Human Research Protection Regulations.