Clinical Research Coordinator B/C (Abramson Cancer Center)

Summary

The University of Pennsylvania is a prestigious institution known for its leadership in education and research. The Clinical Research Coordinator B/C will play a vital role in executing clinical trials at the Abramson Cancer Center, ensuring compliance with protocols and federal regulations while supporting the research team in various capacities.

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
• Assist with 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
• Assist 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
• Coordinate 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.). Assist 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
• Plan, organize, and run study-related meetings, including but not limited to Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits and ongoing training sessions
• Take a lead role in Site Feasibility and Qualification Visits; work in conjunction with the Unit Managers to initiate start-up processes for industry-sponsored and Investigator-initiated trials; independently manage the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials inclusive of managing multi-site projects where Penn is the lead site
• Prepare components of submissions to the IRB (and other entities) and remain aware of the regulatory statuses for assigned protocols; may be asked to draft or edit study protocols and associated documents (e.g., informed consent, manuals of procedures, etc.)
• Participate in the development of study-specific Case Report Forms and other data collection tools; may be asked to contribute to study reports, abstracts, posters, manuscripts, and grant applications
• Participate in Sponsor teleconferences, Program meetings, and working groups that will maximize the efficiency and quality of research performed; may be responsible for orientation/mentorship of new staff and act as a resource to current staff members with study-related issues; provide coverage and support to other Coordinators to meet departmental/organizational staffing needs
• Assist the Unit Managers with QA processes related to research studies; take a lead role in preparing for any inspection (e.g. internal and external audits) that takes place with the trials, as required

Skills

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

Qualifications

Must Haves

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

Benefits

• Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare.
• You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Take advantage of Penn's exceptional tuition benefits.
• You, your spouse, and your dependent children can get tuition assistance here at Penn.
• Your dependent children are also eligible for tuition assistance at other institutions.
• Penn offers generous retirement plans to help you save for your future.
• Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis.
• Choose from a wide variety of investment options through TIAA and Vanguard.
• Penn provides you with a substantial amount of time away from work during the course of the year.
• 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.
• If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements.
• Eligible family members must always provide proof of good health and are subject to underwriting.
• Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life.
• Penn provides an array of resources to help you advance yourself personally and professionally.
• As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities.
• Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries.
• Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff.
• You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments.
• 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.
• 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.