Clinical Research Coordinator B​/C; Abramson Cancer Center

Overview

The University of Pennsylvania is a private employer with a long-standing tradition in education, research, and innovation. Penn offers opportunities for undergraduate, graduate and continuing education, and emphasizes interdisciplinary scholarship. Penn has been recognized as one of America’s Best Large Employers in 2023 by Forbes.

Penn provides a competitive benefits package including healthcare, tuition benefits for employees and families, retirement plans, professional development, supportive work and family benefits, wellness programs, and more.

Posted Job Title

Clinical Research Coordinator B/C (Abramson Cancer Center)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants.

The ACC CRU supports disease/discipline specific medical oncology cancer programs within the ACC and is comprised of 12 Research Teams.

The Clinical and Translational Research Program for Lymphomas and Other Related Diseases (“Lymphoma Research Team”) within the ACC CRU seeks a full-time Clinical Research Coordinator B/C (CRC). The successful candidate will (1) ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and other federal/institutional requirements, and (2) meet required obligations to patients/subjects, Principal Investigator (PI), study team and Sponsor/CRO.

This position reports to the Program Manager and works with PIs and clinical research nurses (CRNs).

The CRC is an integral and essential member of the ACC CRU Lymphoma Research Team. We seek an enthusiastic, professional, and committed team member to collaborate with investigators, team leaders, CRNs, and other research staff. The ACC has received an exceptional rating from the National Cancer Institute (NCI) and is considered a top cancer center. We aim to accelerate this momentum through cutting-edge clinical trials.

Job Description

Clinical Research Coordinator B Responsibilities:

This individual will work under general supervision. Specific responsibilities include (but are not limited to):

• Plan, organize, and contribute to study-related meetings, including Investigator Meetings, Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits, and ongoing training sessions; maintain complete and accurate records of meetings/sessions, and ensure action items are completed in a timely manner.
• Assist with start-up processes for Industry-sponsored, Cooperative Group, and Investigator-initiated studies; review protocols and manuals, pursue corrections or clarifications as needed; coordinate non-therapeutic studies and complex Phase I, II, or III oncology trials.
• Assist the Regulatory Coordinator by preparing components of submissions and drafting responses to IRB stipulations; monitor regulatory statuses for assigned protocols.
• Lead or contribute to Informed Consent in accordance with federal and state law. Review inclusion/exclusion criteria and facilitate eligibility review with Sponsor/CRO as required.
• Provide support to faculty and staff during study-related visits; document visits and testing; coordinate exception requests and deviations; document and report adverse events and other events.
• Collect, review and report data in accordance with study timelines; resolve data discrepancies and respond to sponsor queries; manage deviations and other events.
• Coordinate independent central review of end-points (e.g., imaging data); manage transport and processing of biological materials; assist with billing reconciliation and patient stipends; may assist with research scheduling.
• Maintain complete, organized, audit-ready study and participant files; secure signatures and forward documents; maintain Delegation of Authority log.
• Participate in research meetings and Sponsor/CRO teleconferences; provide coverage to meet departmental needs; maintain trainings and certifications (e.g., CITI, GCP, IATA, Penn CRC Certificate, Penn Profiler trainings).
• Perform other duties as reasonably assigned.

Clinical Research Coordinator C Responsibilities:

The CRC C will work independently under minimal supervision and may act in a lead capacity or as back-up to the Supervisor. Responsibilities are the same as B but with additional duties:

• Plan, organize, and run study-related meetings and ongoing trainings.
• Lead Site Feasibility and Qualification Visits; initiate start-up processes for industry-sponsored and Investigator-initiated trials; manage complex Phase I–IV trials including multi-site projects where Penn is the lead site.
• Prepare submissions to IRB and other entities; monitor…