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Senior Clinical Science Professional, University of Colorado, Anschutz Medical Campus
Nature of Work
Senior Clinical Science 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. Senior Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research.
Examples of Duties Performed- 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 trial
- 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 clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
- Schedule subject participation in research clinical trial, 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
- 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
- Act as a Primary Coordinator on multiple trials/studies
- Assist and train junior team members
- 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
- Assist with motion capture testing as needed, including marker placement, data collection using Vicon camera system and Bertec force plates, and data analysis using Visual 3D software
- Manage implementation, control, and reporting on participant research tests. Assist the research team with test performance as needed in person or via telehealth processes. Maintain records and prepare project administrative and statistical reports as needed. Draft and maintain all documentation required for the outcome measurement for studies.
- Lead in-person physical function testing for study participants. Maximize safety for all participants by using appropriate guarding techniques and professional judgement. Follow all COVID-19 safety protocols.
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.
Minimum Qualifications- Bachelor’s degree in science or health related field
- A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis
- Two (2) years clinical research or related experience
Preferred Qualifications- Master’s degree in science or health related field
- Three (3) years of clinical research or related experience
- Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
- Experience with instrumented motion capture systems for outcomes testing (e.g., 3D video motion capture, force plates, wearable motion sensors)
- Current CPR Certification
Competencies, Knowledge, Skills, and Abilities- Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
- Ability to communicate effectively, both in writing and orally
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
- Outstanding customer service skills including the ability to supervise exercise programs for people of diverse backgrounds
- Must enjoy and be effective talking on the telephone and interacting in-person with older adults to assess participant interest, schedule testing sessions, and perform any follow-up study coordination necessary
- Demonstrated commitment and leadership ability to advance diversity and inclusion
- Knowledge of basic human anatomy, physiology medical terminology
- Ability to interpret and master complex research protocol information
For questions, contact Emily Hager, emily.hager@cuanschutz.edu
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