Clinical Sciences Research Professional, Open Rank

University of Colorado; United States; Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

University of Colorado Anschutz in the Pediatric Orthopedics division is seeking a Clinical Sciences Research Professional (Open Rank) to support Principal Investigators in surgical sports medicine research at Children’s Hospital Colorado. The role involves patient-oriented clinical research, regulatory tasks, data management, and coordinating multi-site studies.

The position is housed within Children’s Hospital Colorado Anschutz and may require occasional travel to clinics across the Denver

Responsabilidades

• Assist with and oversee the day-to-day operations of clinical trials and studies
• Obtain study subject's medical history and current medication information, review protocol inclusion/exclusion criteria, and confirm eligibility
• Perform informed consent process or ensure proper documentation
• Interview prospective subjects and educate them about studies
• Schedule subject participation and coordinate site resources
• Collect, code, and analyze data from research projects accurately
• Maintain regulatory compliance with FDA and study protocols
• Support subject recruitment and screen participants
• Ensure supplies and equipment are in stock and functional
• Collect and process samples for biobanking
• Maintain regulatory software like REDCap, OnCore, Florence eBinder
• Document research encounters and IRB protocol development/maintenance
• Coordinate with external sites on multi-site studies and data quality
• Provide budget tracking and act as a study initiation/close-out resource
• Serve as Primary Coordinator on multiple trials/studies
• Participate in committees related to the Musculoskeletal Research Center
• Advance processes, train junior staff, and implement quality improvements
• Develop protocol-specific systems and SOPs to support trials

Descripción del empleo

University of Colorado Anschutz
Department: Orthopedics
Job Title: Clinical Sciences Research Professional, Open Rank
Position #: 00808632 - Requisition #:41604

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

• 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