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The Abramson Cancer Center Clinical Research Unit (CRU) of the University of Pennsylvania seeks a full-time Clinical Trials Coordinator B to organize, coordinate and implement studies involving a wide variety of investigational products and various sponsors. This position will report to the unit managers of a specific disease-site and work closely with a Physician Investigator to oversee all aspects of clinical research performed within his/her area of interest. This includes subject recruitment, detailed data entry, subject visits and follow-up, processing and shipping subject specimens, maintaining study supplies, and regulatory documentation. This individual will work under general supervision. Specific responsibilities include (but are not limited to):* Assist unit managers with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials. Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. * Coordinate the conduct of complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I IV clinical trials and registries. Organize and maintain all documentation required by the sponsor or CRO per GCP includes source documentation, case report forms, and research charts.* Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential subjects in the office or speaking to them by phone, asking pre-screening eligibility questions, etc.).* In collaboration with the PI and Research Nurse, participate in clinic to explain the trial and provide informed consent to the patient and family. Develop, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol. Adhere to all University of Pennsylvania, FDA and GCP guidelines.* Collect, review and report timely, valid, accurate study data. Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time. Maintain clinical trial databases by completing case report forms within the timelines specified by the study-specific Clinical Trials Agreement. Responsible for IND reporting and/or assisting Sponsor with annual IND reporting.* Process and ship study specimens including blood, urine and tissue samples. Obtain slides from pathology and/or scans from radiology and ship to sponsor/independent reviewers per protocol guidelines. Maintain central lab supplies, kits, and/or equipment provided by the sponsor (e.g. EKG machines, ePRO tablets, etc.). Be responsible for billing reconciliation, tracking site reimbursements and allocating patient stipends.* On behalf of the site, participate in weekly or bi-weekly Sponsor teleconferences to review the status of ongoing patients and slot assignments/allocations for next dose levels; share study-wide updates/issues with unit managers and study team members who were not able to participate. * Participate in working groups that will maximize the efficiency and quality of research performed, including developing SOPs. May act as a mentor to coordinators who have joined the unit with less research experience.Position involves work-related responsibilities that may occur outside of usual hours and some conference-related travel. Position is contingent on continued funding.
Bachelors degree and 2-4 years of experience, or an equivalent combination of education and experience required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple research projects; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) knowledge or experience in hematologic malignancies preferred but not required; (6) ability to work flexible hours; (7) possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.
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