Clinical Research Coordinator, Open Rank

University of Colorado

23h•$48,446 - $72,498•Hybrid

About The Position

The Dragoo Research Program, located at the Inverness Orthopedics and Spine Center - Steadman Hawkins Clinic, is seeking a Clinical Research Coordinator (CRC). The Clinical Research Coordinator (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.

Requirements

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
One (1) year clinical research or related experience (Intermediate Level)
Two (2) years clinical research or related experience (Senior Level)
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

Nice To Haves

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): o CCRC – Certified Clinical Research Coordinator o CCRP – Certified Clinical Research Professional o CCRA – Certified Clinical Research Associate

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 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
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
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.