"Clinical Research Coordinator B/C"

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Posted Job Title

Clinical Research Coordinator B/C

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 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. 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 include 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; and preparation and submission of materials to the Penn Biomedical Institutional Review Board (IRB) and central IRBs, as applicable. The Clinical Research Coordinator is responsible for supporting all phases of clinical trial execution, including study start-up, ongoing study conduct, monitoring, and close-out activities.
The individual will work 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. This role requires independent coordination of assigned studies, direct communication with investigators, sponsors, and CROs, and a strong commitment to participant safety, protocol compliance, and data quality.
We are seeking a professional who thrives in a dynamic, team-based environment and is committed to advancing clinical research in dermatology. This position offers opportunities for professional growth, with structured training and increasing responsibility commensurate with experience, supporting progression within the Clinical Research Coordinator B/C career pathway.

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.

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. Meet with the Principal Investigator to review participant status, 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.
• Monitor participants per protocol requirements, document adverse events and concomitant medications, and complete safety reporting in a timely and accurate manner. Report adverse events to the sponsor, IRB, and designated oversight groups in accordance with study and institutional requirements.
• Prepare study start-up materials, including visit guides, source documentation tools, participant binders, e-regulatory binders, and required tracking logs. Assemble and submit documents to institutional committees (e.g., IRB, CTSRMC) to support study activation. Confirm workflow feasibility with clinic operations and ensure readiness prior to first enrollment.
• 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. Ensure data entry, document updates, and data queries are addressed within study timelines.
• 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.
• Perform additional duties as assigned

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.

Clinical Research Coordinator B: Bachelor's degree and 2-3 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple research projects; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) possess working knowledge of International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines.

Clinical Research Coordinator C: Bachelor's degree and 4-5 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple therapeutic research protocols; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) possess working knowledge of International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines.

This position is contingent upon funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$52,500.00 - $67,046.00 Annual Rate

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.