Clinical Research Coordinator
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The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Job Description Summary
The Clinical and Translational Research Program for Lymphomas and Other Related Diseases (“Program”) of the University of Pennsylvania seeks a full-time Clinical Research Coordinator B (“Coordinator”). This position 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 individual will work under general supervision.
- 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.
- Position involves some conference-related travel. Work-related responsibilities may occur outside of regular business hours. Position is contingent on continued funding
THIS POSITION IS CONTINGENT UPON FUNDING
BS/BA (preferably in a life science area) and 2-4 years of experience, or equivalent combination of education and experience, are required. Candidate must have practical experience coordinating the day-to-day activities of multiple research protocols and working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.
Job Location - City, State
Department / School
Perelman School of Medicine
$42,953.00 - $77,315.00
Affirmative Action Statement
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Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.