"Clinical Research Coordinator, Open Rank"

Clinical Research Coordinator, Open Rank

University of Colorado Anschutz Medical Campus
Department: Orthopedics

Job Summary

The Dragoo Research Program, located at the Inverness Orthopedics and Spine Center - Steadman Hawkins Clinic, is seeking a Clinical Research Coordinator (CRC). The CRC will engage in a variety of clinical research activities, including patient-oriented research, human subject studies, and laboratory procedures. Additionally, the CRC will be responsible for conducting standard complete blood count procedures for orthobiologic cases in a CLIA-accredited laboratory.

Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. CRC professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. The CRC role requires proficient communication with several entities, physicians, and researchers, as well as leading clinical trials and regulatory requirements for human subject research. The CRC will be responsible for maintaining a thorough understanding of assigned human subject research protocols and projects, particularly focusing on the biobanking initiative, investigator-initiated studies, and industry-sponsored research. The CRC will report to the Program Manager and provide technical and administrative assistance to Dr. Jason Dragoo's research team. Duties include engagement in technical research activities, laboratory functions, data entry and oversight using electronic systems, and ensuring compliance with reporting requirements for protocols and projects.

Key Responsibilities

All Levels:

• 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

Intermediate Level: All duties referenced above, plus:
- 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

Senior Level: All duties referenced above, plus:
- 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

Additional Duties & Responsibilities

• Performs biospecimen collections and other required biorepository activities as needed.
• Conduct laboratory tests (i.e., complete blood count, etc.), manage inventory, maintain instrumentation/equipment, and perform various lab procedures.
• Adhere to CLIA laboratory guidelines and laboratory procedures.
• Coordinate the transportation and shipment of biospecimens, along with other essential clinical trial materials.
• Performs other related duties as required by the management team.
• Work independently or in a team-based setting to collaborate on research objectives.
• Completes and maintains all training requirements for biohazard material handling and shipping requirements.

Work Location

Hybrid - this role is eligible for a hybrid schedule of some days per week onsite and as needed for in-person meetings. Specific schedule will be determined by the hiring manager. NOTE: This position's onsite work will be performed primarily at the Steadman Hawkins Inverness UCHealth Clinic in Englewood, CO.

Qualifications

Minimum Qualifications
Entry Level: Bachelor's degree in any field (A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis)
Intermediate Level: Bachelor's degree in any field (substitution allowed) + One (1) year clinical research or related experience
Senior Level: Bachelor's degree in any field (substitution allowed) + Two (2) years clinical research or related experience

Preferred Qualifications

• Bachelor'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).
• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP) and Good Laboratory Practice.
• Additional certification (one of the following): CCRC - Certified Clinical Research Coordinator, CCRP - Certified Clinical Research Professional, CCRA - Certified Clinical Research Associate

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
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information

Anticipated Pay Range

Entry: $48,446-$61,623
Intermediate: $52,721-$67,061
Senior: $56,995-$72,498