Clinical Research Coordinator

Number of Positions In Requisition 1 Job Details A full-time Clinical Research Coordinator position is available in the Lung Cancer Screening and Lung Nodule Program of the Korman Respiratory Institute, Division of Pulmonary and Critical Care Medicine. The role is in-person at the Jefferson TJUH campus in Center City Philadelphia. Works under limited supervision and oversees the day-to-day activities of clinical trials in accordance with Good Clinical Research Practice (GCP). Performs a variety of research activities in support of clinical trials, including database management, biological specimen collection and processing, study coordination, recruitment, assisting with informed consent and conducting study visits. The Clinical Research Coordinator will support clinical research activities focused on lung cancer screening, low-dose CT (LDCT) imaging, novel biomarker evaluation, and early-detection technologies. The position will assist investigators with organizing, gathering, compiling, and maintaining clinical research data and documentation across observational and interventional protocols. Job Description Essential Functions Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson. Performs a variety of research, database, biospecimen collection and processing, as well as clerical duties in support of clinical trials to assist investigators in organizing, gathering, and compiling clinical research data. Organizes and maintains documentation required for clinical trial(s). Informs Principal Investigator and/or designated individual on any issues concerning patients' response to treatment/medication and any adverse effects overall to patients. Assists Principal Investigator with regulatory body filings, including IRB submissions. May assist in the enrollment of human subjects. May provide clerical and technical support to ensure adherence to research protocols and quality of information received. Reviews electronic health records (EHR) and clinic schedules to identify potentially eligible high-risk patients for lung cancer screening and early-detection clinical trials based on study-specific criteria. Assists with patient recruitment and screening activities and serves as a point of contact for study participants throughout the research process. Assists with informed consent and enrollment activities in accordance with IRB-approved protocols and institutional policies. Schedules and coordinates clinical research visits, low-dose CT (LDCT) screenings, and other research procedures in coordination with clinical care teams. Collects, processes, stores, and ships biospecimens, including blood, tissue, and sputum, in accordance with study protocols and applicable handling and shipping requirements. Enters and abstracts clinical research data from electronic health record systems into electronic data capture (EDC) platforms and other research databases. Resolves data queries in a timely manner and maintains accurate and audit-ready source documentation. Records study results and tracks patients who are due for follow-up within the Lung Cancer Screening Program using designated radiology tracking software. Training will be provided. Maintains regulatory and study documentation and assists with preparation and maintenance of regulatory binders and study files. Supports clinical trial monitoring and audit activities by ensuring study documentation and data are maintained in accordance with applicable protocols, GCP guidelines, FDA regulations, and institutional policies. Provides ongoing study-related education to participants, assists with follow-up scheduling, and helps address barriers to study participation and retention. Minimum Education and Experience Requirements Minimum Education: High School Diploma or equivalent. Experience: High School Diploma or equivalent and 4 years of relevant experience, or Bachelor’s degree/Master’s degree and previous experience preferred. Preferred Qualifications Bachelor’s or Master’s degree in a relevant field such as health sciences, biology, public health, nursing, or a related discipline. Previous clinical research experience, particularly in oncology, pulmonary medicine, lung cancer screening, or other related clinical research settings. Experience with clinical trial coordination, patient recruitment, informed consent, electronic data capture systems, regulatory documentation, or biospecimen collection and processing. Familiarity with Good Clinical Practice (GCP), FDA regulations, IRB requirements, and clinical research documentation. Additional Information Full-time, in-person position at the Jefferson TJUH campus in Center City Philadelphia. Training will be provided on designated radiology tracking software and other program-specific systems as needed. The position supports both observational and interventional clinical research protocols within the Lung Cancer Screening and Lung Nodule Program. Work Shift Workday Day (United States of America) Worker Sub Type Regular Employee Entity Thomas Jefferson University Primary Location Address 800-803 Walnut Street, Philadelphia, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce