The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The Hematology Clinical Trials Unit is looking to hire a full time Regulatory Affairs Coordinator (RAC). The primary focus of this role would include start up, maintenance and closure of Investigator Initiated Trials (IIT). This role will also serve as backup to other RAC’s working on industry sponsored trials.
Examples of Work Performed
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:
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
Education: BS or BA in any field
Experience: One or more years of clinical and/or research experience.
Knowledge, Skills & Abilities
Ability to problem solve and multi-task.
Ability to work independently.
Good command of the English language, both written and verbal.
Strong interpersonal and human relations skills.
Ability to work independently, identify and set priorities, and meet deadlines in a fast-paced work environment.
Understanding of research standard as set forth by FDA, OHRP, UCH, UCD and NCI
Excellent computer skills. Proficient in Windows, MS Word, Excel, Access, PowerPoint
Experience: 3+ years research and/or regulatory experience
Certification w/CCRC, CCRA, or RAC
Additional Salary Information: Salary is commensurate of skills and experience.
Internal Number: 00722739
About University of Colorado Denver Division of Hematology
The Division of Hematology at the University of Colorado and its clinical partner, the Blood Disorders and Cellular Therapy Center at UCHealth, have a shared mission: to deliver the best possible care to persons with blood cancer and other blood diseases and always seek to make today’s care better for tomorrow through research, innovation and education.
To achieve these goals, specialist-based disease-focused groups have been established to deliver the most expert clinical care, as well as to conduct laboratory and clinical research aimed at improving treatment outcomes, reducing side effects and improving quality of life.