Clinical Research Coordinator B/C (Abramson Cancer Center)

About the role

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 is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments.

Responsibilities

• Plan, organize, and contribute to study-related meetings, including but not limited to 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 that resulting action items are completed in a timely manner.
• Aid in start-up processes for Industry-sponsored, Cooperative Group, and Investigator-initiated studies; proactively review protocols and associated manuals, ask questions, and pursue corrections or clarifications, if needed.
• Coordinate non-therapeutic studies and complex Phase I, II, or III oncology clinical trials.
• Aid the Regulatory Coordinator by preparing components of submissions (e.g., institutional forms, initial submissions, amendments, continuations, etc.) and drafting responses to IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols.
• Lead or contribute to Informed Consent in accordance with federal and Pennsylvania state law. Review inclusion/exclusion criteria with other members of the study team and facilitate eligibility review with the Sponsor/CRO, if required.
• Provide support to faculty and staff during study-related visits. Ensure timely and appropriate documentation of visits and testing. Coordinate exception requests (or prospective deviations); document and report adverse events, serious adverse events, events of interest, and non-medical events.
• Collect, review and report timely, valid, and accurate data within the timelines specified by the study-specific Agreement; this includes resolving data discrepancies and timely response to sponsor queries; timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission.
• Maintain an up-to-date list of incidental (i.e., minor) deviations; coordinate reportable (i.e., major) deviations and other unexpected events.
• Care for independent central review of clinical trial end-points (e.g., imaging data).
• Transport, process and ship biological materials (e.g., blood, urine, tissue, etc.) using universal precautions. Receive and maintain central lab supplies, kits, and equipment (e.g., EKG machines, ePRO tablets, etc.).
• Aid with billing reconciliation, tracking site reimbursements and allocating patient stipends. May be asked to assist with research scheduling.
• Maintain complete, well-organized, and audit-ready study and participant files (e.g., subject charts, case report forms, enrollment logs, hospital records, etc.) from participant screening through final follow-up. Secure signatures and forward documents/forms (e.g., FDFs, PSPs, FDA 1572, etc.) to appropriate destinations; maintain Delegation of Authority log.
• Participate in research meetings (e.g., team, disease-site, etc.) and Sponsor/CRO teleconferences. Provide coverage and support to meet departmental and organizational staffing needs (i.e., lunches, sick calls, vacations, or when a specific team member’s workload exceeds capacity).
• Maintain all relevant trainings and certifications (e.g., CITI, GCP, IATA, PENN CRC Certificate, Penn Profiler trainings, etc.). Make use of available resources and established procedures to identify problems ideally before they happen.
• Perform other duties as reasonably assigned.

Qualifications

• For Clinical Research Coordinator B: Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
• For Clinical Research Coordinator C: Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.