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In collaboration with the Associate Dean for Cancer Clinical Research and the Administrative Director of the Cancer Institute Clinical Trials Office, the Workforce Development Educator and Trainer supports the growth and development of the Penn State Clinical Trials Office (CTO) by achieving strategic objectives including overseeing multiple project activities related to training and education of clinical research staff and investigators.
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Under the supervision of the Department of Surgery Research Administrator, the Research Nurse will conduct Clinical Trials in adherence with FDA, IRB, Pennsylvania, and related regulations.
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Assists with NORI/IRB submissions and maintenance of regulatory and legal documents; maintains required documentation for clinical trials. Plans, implements, and conducts approved clinical research trials by coordinating and managing the patient assessments, phlebotomy, drug administration, and monitoring of side effects according to protocol standards in a clinically safe and regulatory compliant manner involving research patients who have multiple disease processes to ensure timely, high quality care across the care continuum.
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The research coordinator will also be responsible for working with the overall study coordinator and Clinical Trials Manager to insure appropriate adherence to study protocols and timelines.
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The Clinical Research Coordinator A will recruit and screen patients as outlined in research protocols, will coordinate all research visit activities for assigned projects (including processing and shipping blood and urine samples), and will assist in the maintenance of research records in compliance with IRB and HIPAA regulations.
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The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Velocity’s SOPs.
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We value prior experience as a Principal Investigator or Project Director under federal grants or cooperative agreements, familiarity with award processes, experience as a PI on industry sponsored clinical trials and/or investigator initiated research, and/or knowledge of regulatory requirements of the FDA, GCP, and applicable IRB/IACUC requirements.
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Compiles and monitors information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials. Under minimal supervision is responsible for the research regulatory and administrative activities of clinical trials for the practice.
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Knowledge of NIH and FDA regulations regarding clinical trials. Working under general supervision of the Assistant Director of Clinical Trial Operations, this position assumes responsibility for the overall management of assigned clinical trials/studies.
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Scientists and researchers for the Center for Regenerative and Personalized Medicine (CRPM) are underway on several research projects, including SPRI's federally funded clinical trials, preclinical projects and research programs sponsored by philanthropy.
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Job Summary The Clinical Research Nurse, under the guidance and supervision of the Research & Bioethics Manager, assists the Principal Investigator (PI) and Study Coordinator in ensuring the integrity and quality of clinical trials are maintained and conducted in compliance with federal and state regulations, Institutional Review Board (IRB) approvals, and Hendrick Health policies and procedures.
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Supports IRB approved clinical research/trials though a variety of activities including but not limited to: obtaining consent; ordering diagnostic tests; recording laboratory and diagnostic results; administering therapeutic interventions; and documenting and reporting patient outcomes including toxicities or adverseevents.
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Establishes research program goals and objectives and directs clinical trials program evaluation and quality control activities; develops and/or approves schedules, priorities, and standards for achieving goals.
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Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. The Clinical Research Coordinator work within the GYN Oncology clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator.
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The regulatory agencies include the University IRB, clinical trials office, and the FDA. Ensure integrity of all study data collected. Coordinates and oversees the Pediatric Clinical Research Program within the Division of Pediatric Hematology/Oncology including the cooperative group protocols through Children's Oncology Group (COG) and Dana Farber Cancer Institute (DFCI), investigator-initiated, compassionate-use, and pharmaceutical research projects.
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