Clinical Research Coordinator (Level II and III) – Satellite location

University of Colorado•Aurora, CO

1d•Hybrid

About The Position

Clinical Science Professionals at all levels 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. Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Key Responsibilities: Level of clinical or data focused tasks will be determined at the discretion of the supervisor/manager based on team needs. Intermediate Level or CRC II, all the above and: · 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 or CRC III, all the above and: · Assist with developing or develop 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 · 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 This description is a summary only and describes 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 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 of professional clinical research experience and/or professional clinical experience post Bachelor’s degree
Applicants must meet minimum qualifications at the time of application.
Applicants must be legally authorized to work in the United States without the need for employer-sponsored work authorization.
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)
Additional certification (one of the following):
CCRC – Certified Clinical Research Coordinator
CCRP – Certified Clinical Research Professional
CCRA – Certified Clinical Research Associate

Responsibilities

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 develop 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
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