Centralized Clinical Trial Manager at ICON responsible for reviewing clinical trial site visit reports and ensuring quality standards. Act as a liaison for timely resolution of issues.
About the role
- Clinical Research Coordinator managing clinical trials and studies at the University of Colorado Cancer Center. Collaborating on cancer research projects and maintaining regulatory compliance.
Responsibilities
- Assist with and oversee the day-to-day operations of clinical trials and studies
- Independently abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into clinical trials database
- 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
- Interview prospective subjects for a variety of research clinical trials and educate potential subjects on the details of the studies
- Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support
- Collaborate with other clinical research team members, investigators, and hospital staff to ensure tests and procedures required by research protocols are performed and documented
- Meet with Monitors to respond to any questions of data validity and correct/revise data as appropriate; responds to queries from Sponsor
- Adhere to research regulatory standards
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
- Entry Level or CRC I: No specific experience
- Intermediate Level or CRC II: One (1) year of professional clinical research experience and/or professional clinical experience post Bachelor’s degree
- Senior Level or CRC III: One (1) year of professional clinical research experience and one (1) year of professional clinical experience post Bachelor’s degree
- 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)
- Additional certification (one of the following): CCRC – Certified Clinical Research Coordinator, CCRP – Certified Clinical Research Professional, CCRA – Certified Clinical Research Associate
- Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
Benefits
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10% of your gross pay
- Paid Time Off: Accruals over the year
- 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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