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