The Clinical Research Unit Genetics Research Team at the Abramson Cancer Center of the University of Pennsylvania seeks a full-time Clinical Trials Coordinator to organize, coordinate and implement studies involving a wide variety of investigational products and various sponsors. He/she will be responsible for all aspects of clinical trial coordination including: subject recruitment, detailed data entry, subject visits and follow-up and regulatory documentation.
Clinical Trials Coordinator B: This individual will work under general supervision. 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. Interface with regulatory authorities, Sponsors and cooperative groups as directed by the supervisor. 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 within the Clinical Research Program. Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens. Maintain Delegation of Authority Logs. Coordinate completion and appropriate documentation of study staff training. 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.). 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 and in accordance with Good Clinical Practice (‘GCP’) (e.g. scheduling subject visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities). Ensure drug accountability and appropriate diary completion. Ensure adequate drug supply and assist Pharmacist with ordering if needed. Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Participate in the development/maintenance of study specific case report forms and source document tools. May include the development and management of REDCAP web sites for internet data capture. Organize and maintain all documentation required by the sponsor or CRO per GCP – includes source documentation, case report forms, and research charts. Collect, review and report timely, valid, accurate study data. Obtain records required to complete case report forms. Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time. Maintain clinical trial databases by completing case report forms within 5 business days of subject visits and resolving data queries within 10 days of issuance. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission. Responsible for IND reporting and/or assisting Sponsor with annual IND reporting. 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. Coordinate and participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Prepare agendas and record minutes for circulation. Provide regular updates to the research team and unit managers. Assist unit managers in meeting project timelines. Participate in working groups within the Genetics Clinical Research Program that will maximize the efficiency and quality of research performed, including developing SOP’s. May act as a mentor to coordinators who have joined the unit with less research experience
Clinical Trials Coordinator C: The Clinical Trials Coordinator C will have the same duties as B but will include the following:
* This individual will work independently with minimal supervision. May act in a lead capacity or as back-up to supervisor. * Work directly with physicians to design, set-up and execute studies. Be responsible for writing investigator initiated IND/IDE clinical trials in collaboration with faculty supervisor. Speak at investigator meetings or site initiation visits for IITs where physician is the national Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; assist with literature reviews; contribute to the preparation of study abstracts, posters, manuscripts and grant applications. * Work in conjunction with unit managers * Participate in budget preparation for trials as needed. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required * Independently manage complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials and registries within the Genetics Clinical Research Program. This includes managing various aspects of multi-center trials such as working with partnering institutions on budgets and IRB documentation, and monitoring external research sites. * Develop, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (‘GCP’) (e.g. scheduling subject visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, coordinating treatment administration and/or procedures with physician or NP, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities). * Act in lead capacity in coordination of unit projects and assist unit managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinators/assistants who provide study related support (e.g., regulatory submissions and data entry). May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues. Act as back-up to the unit managers when required.
Internal Number: 41673
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