Clinical Research Coordinator (Level II and III) – Satellite location
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.
- 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
- 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
- Benefits
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10%25 of your gross pay
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 10/year
- Tuition Benefit: Employees have access to this benefit on all CU campuses
- ECO Pass: Reduced rate RTD Bus and light rail service
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