The Clinical and Translational Research Program for Lymphomas and Other Related Diseases (‘Program’) of the University of Pennsylvania seeks a full-time Clinical Trials Coordinator B. 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/subject, Principal Investigator, study team and Sponsor/CRO.
This individual will work under general supervision. Specific responsibilities include (but are not limited to): * Plan, organize, and contribute to study-related meetings, including but not limited to Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits and ongoing training sessions; maintain complete and accurate records of all meetings and training sessions, and ensure that resulting action items are completed in a timely manner. * Participate in Site Feasibility and Qualification Visits; assist the Unit Managers to initiate start-up processes for industry-sponsored and Investigator-initiated trials; coordinate the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials. * Assist the Regulatory Coordinator by preparing components of submissions to the IRB (and other entities), respond to IRB queries or concerns, and remain aware of the regulatory statuses for assigned protocols. * Responsible, in conjunction with the study team, for ensuring successful patient recruitment and enrollment goals are met within specified timelines; developing/implementing recruitment strategies, assessing effectiveness of recruitment efforts, and reporting recruitment/retention status to the Program Manager. * Conduct informed consent process (i.e., non-interventional studies), contribute to informed consent discussion (i.e., interventional studies) and ensure appropriate documentation of consent; review inclusion/exclusion criteria with PI/Nurse and facilitate eligibility review with the Sponsor, if required; develop, schedule, and oversee subject visits in conjunction with the Study Team; show vigilance in patient safety, protocol compliance and data quality; adhere to all University of Pennsylvania, FDA and GCP guidelines. * Collect, prepare, ship and/or store biological materials using universal precautions; facilitate independent review of tissue samples and imaging studies with internal and external collaborators; receive and maintain central lab supplies, kits, and equipment provided by the Sponsor; assist with billing reconciliation, tracking site reimbursements and allocating patient stipends. * Maintain complete, accurate, and well-organized study files from patient screening through final follow-up; keep files in an up-to-date and audit-ready state; participate in the development of study-specific Case Report Forms and other data collection tools; secure signatures and forward documents/forms to appropriate destination; maintain Delegation of Authority log. * Collect, review and report timely, valid, accurate study data within the timelines specified by the study Agreement; document and report (i.e., to regulatory/governing bodies) adverse events, serious adverse events, and other events of interest; maintain up-to-date list of incidental (i.e., minor) deviations; contribute information to reportable (i.e., major) deviations, other unexpected events and exception requests; coordinate IND safety reporting; ensure appropriate follow-up by the Principal Investigator. * Participate in Sponsor teleconferences, Program meetings, and working groups that will maximize the efficiency and quality of research performed; act as a mentor to Coordinators who have joined the unit with less research experience; provide coverage and support to other Coordinators to meet departmental/organizational staffing needs. * Perform other duties as reasonably assigned.
Position involves work-related responsibilities that may occur outside of usual hours and some conference-related travel. Position is contingent on continued funding.
Internal Number: 45834
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