- Develop and 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 and study site recruitment efforts, including communicating with patients and affiliate stakeholders expressing an interest and all pre-screening/screening activities
- 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 and site-specific documentation and prepares documents and reports
- 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
- Support management of the RESTORE research portfolio and expedite the successful execution and dissemination of research outcomes and deliverables
- Manage the implementation of new and ongoing research studies involving medically complex patients including facilitating the completion of a large, multi-site pragmatic study involving Skilled Nursing Facilities (SNFs) throughout the United States
- Create and manage large, complex research databases (including staff education, data cleaning, and report generation) and coordinate with biostatistician team as needed. Request and coordinate access to and/or transfer of large data sets
- Oversee all facets of research project operations including study equipment; survey creation, distribution, and reminders; research site learner materials; project dashboard; site visit materials and timing of travel to sites; scheduling of virtual site meetings, check-in meetings and focus groups
Senior Clinical Science Professional - Aurora, United States - University of Colorado
Description
Senior Clinical Science Professional-32975University Staff DescriptionUniversity of Colorado Anschutz Medical Campus
Department: Physical Medicine and Rehabilitation/Physical Therapy Program
Job Title: Research Services Senior Clinical Sciences Professional
Position # – Requisition #32975
Job Summary:
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. Some Assignments will not move beyond this level.
Key Responsibilities:
Additional Examples of Work Performed:
Work Location:
Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.
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