Job Summary: | The University of Colorado Department of Pediatric Orthopedics has an opening for a Clinical Services Research Professional. The primary focus of this position will be to support Principal Investigators in the surgical sports medicine subspecialty at Children’s Hospital Colorado. This position is within a team of research professionals and as such a secondary focus will be to familiarize themselves with the studies of other Children’s Hospital Orthopedics Institute Providers. Clinical Science Research Professionals perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Research Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. The position is part of the Musculoskeletal Research Center. This position is housed within Children's Hospital Colorado Anschutz and will require occasional travel to clinics throughout the Denver metro area. Key Responsibilities: All Levels (Entry, Intermediate, and Senior) Assist with and oversee the day-to-day operations of clinical trials and studies Obtain study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical research studies Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required Interview prospective subjects for a variety of research studies. Educate potential subjects on the details of the studies through phone contacts and personal interviews Schedule subject participation in research studies, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy) Collect, code, and analyze data obtained from research in an accurate and timely manner Adhere to research regulatory standards Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities Ensure that the necessary supplies and equipment for studies are in stock and in working order Sample collection and processing for biobanking Maintain regulatory software applications such as REDCap, OnCore, and Florence eBinder Properly document research encounters IRB protocol development, submission and maintenance Communicate with other sites and ensure data quality with collaborators from external institutions who are participating in multi-site studies Provide budget and financial allocation tracking Serve as a resource and participate in study initiation and close out duties Act as a Primary Coordinator on multiple trials/studies All research professionals within the Musculoskeletal Research Center are required to serve on one committee, related to advancing the mission of the MRC
Intermediate Level: In addition to the duties above… Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives Assist and train junior team members Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
Senior Level: In addition to the duties above… Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies Assist with identifying issues related to operational efficiency and shares results with leadership Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention Serve as a resource and participate in study initiation and close out duties Lead the development of technical writing for peer-reviewed publication submissions. Prepare and deliver research presentations at professional conferences, including the creation of high-quality presentation materials Extensive content expertise in REDCap, Epic, OnCore and other research platforms Section level research leadership Assist with identifying issues related to operational efficiency and collaborates with leadership for process improvements.
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Why Join Us: | The University of Colorado School of Medicine's Department of Orthopedics is dedicated to advancing orthopedic care through a comprehensive approach that encompasses education, research, and patient care. Comprising a team of renowned orthopedic surgeons, researchers, and educators, the department is committed to excellence in all facets of its mission. From providing cutting-edge educational programs and clinical services to conducting groundbreaking research initiatives, the Department of Orthopedics at the University of Colorado School of Medicine plays a pivotal role in shaping the future of musculoskeletal health. With a focus on innovation, community outreach, and the highest standards of quality, the department stands as a leader in the field, contributing to the well-being of individuals and the advancement of orthopedic knowledge. Why work for the University? We have AMAZING benefits and offer exceptional amounts of hol |