Open Rank Regulatory Affairs Coordinator (RAC) (Entry – Senior)
About The Position
The University of Colorado Division of Hematology, Clinical Trials Unit is seeking a Regulatory Affairs Coordinator. This position is responsible for providing regulatory support for clinical trials and investigator-initiated studies for the Division of Hematology. The Regulatory Affairs Coordinator (RAC) will work closely with the HCTU Leadership Team, Principal Investigators, Industry Sponsor/CRO Representatives, IRBs, and other departments on campus to provide support for the Division’s clinical trial portfolio. This position will provide support for studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials and investigator-initiated studies. The RAC will ensure the accurate progress of clinical research from the planning and approval stages through study completion and post-study closure.
Requirements
- Bachelor’s degree in any field.
- One (1) year clinical regulatory compliance or related experience (for Intermediate Level).
- Two (2) years clinical regulatory compliance or related experience (for Senior Level).
- A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
- Applicants must meet minimum qualifications at the time of hire.
- 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, and medical terminology.
- Ability to interpret and master complex research protocol information.
Nice To Haves
- Bachelor’s degree in science or health related field.
- One (1) to three (3) years of clinical research or related experience.
Responsibilities
- Serves as regulatory contact person for ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.
- Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado. This may include, but is not limited to, the following: Colorado Multiple Institutional Review Board (COMIRB), Protocol Review and Monitoring System (PRMS), Hospital Research Support Services (UCH-RSS), University of Colorado Hospital Biosafety Committee (IBC), University of Colorado Hospital Clinical Trials Research Center (CTRC).
- Writes clear and accurate subject informed consent documents and HIPAA (Health Insurance Portability and Accountability Act) Authorizations.
- Completes and submits continuing reviews, amendments, and safety updates as needed.
- Participates in Data Safety Monitoring Committee (DSMC) internal audits.
- Updates database with regulatory submission and approval dates.
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
- Paid Time Off: Accruals over the year
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 15/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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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
