Regulatory Affairs Coordinator (Open Rank)

University of Colorado•Hybrid, CO

6d•$52,860 - $79,104•Hybrid

About The Position

The Regulatory Affairs Coordinator is an important member of the Cancer Clinical Trials Office Regulatory Affairs team, supporting Phase I–IV industry-sponsored, Cooperative Group (NCTN), and/or investigator-initiated clinical trials in accordance with FDA regulations, Good Clinical Practice, and applicable guidelines and policies. The role provides regulatory management and oversight for clinical trials, including drafting informed consent documents; preparing and submitting study-related regulatory documents to applicable review committees; and supporting clinical teams with the development and submission of Unanticipated Problems. The position serves as a central communication hub among internal stakeholders. It requires attention to detail, strong organizational skills, self-motivation, the ability to manage parallel tasks and deadlines, and effective written and verbal communication. The position is hybrid, with three days per week on campus and additional in-person attendance as needed for meetings. The role is open at RAC I, RAC II, and RAC III levels, with different experience, annual continuing-education, and additional-duty requirements for each level.

Requirements

RAC I: Bachelor’s degree in any field from an accredited college or university, or an allowed substitution.
RAC I: One or more years of professional medical, clinical, and/or research experience.
RAC I: Obtain and track at least 5 continuing education units (CEUs) annually, regardless of whether the employee has an additional certification.
RAC II: Bachelor’s degree in any field from an accredited college or university, or an allowed substitution.
RAC II: Two or more years of professional research experience, including at least one year in oncology and/or academic regulatory experience.
RAC II: Obtain and track at least 10 CEUs annually, regardless of whether the employee has an additional certification.
RAC III: Bachelor’s degree in any field from an accredited college or university, or an allowed substitution.
RAC III: Three or more years of professional regulatory experience, including at least two years of regulatory experience in oncology or a complex academic setting.
RAC III: Obtain and track at least 15 CEUs annually, regardless of whether the employee has an additional certification.
A combination of education and related technical, military, or paraprofessional experience may substitute for a bachelor’s degree on a year-for-year basis.
An advanced degree (master’s or doctorate) in a field directly related to the work assignment may substitute for experience on a year-for-year basis.
Applicants must meet the minimum qualifications at the time of application.
Applicants must be legally authorized to work in the United States without requiring sponsorship; the University cannot provide work visa sponsorship or employment authorization now or in the future.
Work a hybrid schedule, including three days per week on campus.
Demonstrated analytical skills and ability to interpret and master complex research protocol information.
Excellent attention to detail and ability to interpret and master complex research protocol information.
Complex problem-solving skills, including reviewing information, evaluating options, and implementing solutions.
Good command of English and effective written and verbal communication skills.
Ability to establish and maintain effective working relationships, work respectfully with others, maintain confidentiality, and demonstrate teamwork.
Commitment to excellent customer service for internal and external customers.
Ability to adapt to change, manage multiple priorities and deadlines, work independently and as part of a team, and remain organized.
Planning and organization skills, including setting priorities, anticipating obstacles, and managing time effectively.
Ability to use technology to communicate and complete work, including MS Outlook, MS Word, and MS Excel, and to learn new technology.

Nice To Haves

RAC I: At least one year of regulatory experience.
RAC I: Experience working with NCI, industry, and investigator-initiated clinical trials.
RAC I: Experience in an academic and/or medical environment.
RAC II: Experience with FDA submissions for IND or IDE.
RAC III: Working knowledge of FDA regulations and OHRP guidance and how they apply to oncology clinical trials.
RAC III: Professional research certification such as CCRC, CCRP, or CCRA.

Responsibilities

Serve as the regulatory contact for ongoing clinical research studies.
Guide clinical teams on Unanticipated Problem (UAP) or Serious Adverse Event (SAE) reporting.
Work with clinical teams to move protocols through the review process as quickly as possible.
Draft or revise informed consent and HIPAA documents.
Prepare, submit, and track regulatory applications, amendments, continuing reviews, consent documents, and other required study documentation.
Review, submit, and file CIOMS, SUSARS, line listings, IND documents, and other safety reports as needed.
Coordinate submissions to applicable regulatory and institutional review bodies, including COMIRB, WCG IRB, NCI CIRB, and PRMS, and ensure compliance with timelines and approval requirements.
Navigate applicable NCTN websites, including CTSU, SWOG, and NRG Oncology (NSABP, RTOG, GOG).
Maintain regulatory documentation and study milestones in institutional tracking systems, including Advarra OnCore and the eRegulatory management system.
Provide backup coverage during absences of other Regulatory Affairs Coordinators.
For RAC II: Assist with initial Institutional Biosafety Committee (IBC) applications and Single-Patient IND (sIND) and Expanded Access Program processes; provide shadowing of daily tasks for new Regulatory Affairs team members.
For RAC III: Complete required documentation for submissions involving IBC oversight and for sIND and Expanded Access Program processes; assist with training new Regulatory Affairs team members; potentially meet with FDA representatives for record review.