Research Services Clinical Sciences Senior Professional

University of Colorado•Aurora, CO

4d•Onsite

About The Position

We seek a highly motivated, enthusiastic, curious, organized, detail-oriented, and considerate person to become a full-time Senior Clinical Sciences Professional in the B4 Health Lab, in the Department of Physical Medicine and Rehabilitation. The Lab provides an exciting opportunity to participate in basic and translational work on research projects related to the connections between the Brain, Body, Biome, and Behavior to enhance physical and mental health through investigation and education. Senior Clinical Science Professionals perform clinical research related functions which include participant-oriented research or research conducted with human subjects. Participant-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Senior Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. At the senior level, duties involve creating, integrating, applying and sharing knowledge and work is performed fully independently. Some assignments will not move beyond this level. Senior Professionals are responsible for exercising discretion, analytical skills, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. 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.

Requirements

Bachelor's degree in a related field.
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
Two (2) years of research administration experience, including fundamental knowledge of research methods, protocols, data collection, and analysis.
Applicants must be legally authorized to work in the United States without requiring sponsorship.
Confirmed ability to perform duties independently without guidance and direction from other professionals.
Demonstrated ability to interpret and master complex research protocol information.
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.
Demonstrated commitment to providing outstanding customer service skills.
Knowledge of basic human anatomy, physiology, and medical terminology.
Demonstrated understanding and adherence to SOPs, Good Clinical Practice (GCP), IRB, VA, and FDA regulations.
Advanced experience in ensuring all regulatory procedures are completed accurately and on time.
Attention to detail to maintain compliance with all regulatory standards.
Proven ability to manage multiple individual research projects concurrently while maintaining regulatory compliance.
Skills in planning, scheduling, and resource allocation to meet project milestones and goals.
Expertise in maintaining accurate and comprehensive documentation for all studies.
Attention to detail in record-keeping to ensure compliance with regulatory standards.
Proficient skills in developing and maintaining standard operating procedures (SOPs).

Nice To Haves

Master’s degree in science or health related field
Three (3) years of research administration experience, including fundamental knowledge of research methods, protocols, data collection, and analysis.
Proficient experience in REDCap surveys and data entry
Related professional experience as manager, supervisor, work leader, staff authority or project/program administrator.

Responsibilities

Project/Trial Coordination & Protocol Mastery — Serve as Primary Coordinator across multiple projects, independently mastering protocols, SOPs, and essential study documents while performing all project-related procedures in compliance with FDA and regulatory requirements.
Recruitment & Retention — Lead participant recruitment efforts including pre-screening, phone contacts, and in-person interviews; evaluate and implement innovative strategies to maximize enrollment and retention.
Informed Consent & Eligibility — Conduct and document the informed consent process, obtain medical histories and current medications, and confirm participant eligibility against protocol inclusion/exclusion criteria.
Scheduling & Study Logistics — Coordinate subject participation by arranging necessary space, staff support (physicians, nursing, lab, pharmacy), and supplies across all assigned projects.
Data Collection & Recordkeeping — Accurately collect, record, and analyze study data; maintain subject-level documentation; and track and report adverse events to appropriate parties in a timely manner.
Regulatory & Document Management — Develop, review, and maintain regulatory submissions, CRFs, process flows, and training materials to ensure ongoing compliance with FDA, hospital, and departmental standards.
Process Improvement & Dissemination — Support leadership in identifying operational efficiencies, contribute to quality improvement initiatives, and assist with the presentation and publication of research findings.
Additional Duties & Responsibilities — Attend lab and study team meetings. Data entry and quality assurance reviews in REDCap and Excel.