The Department of Neurology has an immediate opening for a full-time Regulatory Affairs Coordinator. The position will independently maintain and manage all IRB and regulatory processes for multi-site sponsored researchstudies relying on a central IRB. Primary duties will include, but not be limited to: submissions to the Institutional Review Board (IRB) of record including amendments, unanticipated problems, continuing reviews, and study closures; maintenance of the investigator site file/regulatory binder and all essential documents including documentation of appropriate training and delegation for all personnel; submissions to internal University and Hospital research portals; acting as primary regulatory contact person for sponsors/Contract Research Organizations (CROs)/coordinating centers; and trainingUCD Neurology Clinic Research personnel to promote good clinical practice (GCP) and compliance with all applicable regulations. The Regulatory Affairs Coordinator will work closely with the Senior Clinical Research Regulatory Manager, subspecialty program managers, and clinical research coordinators.
Key responsibilities include facilitating completion of initial essential regulatory documents (FDA 1572, Financial Disclosure forms, PI signature pages, etc), creating/organizing regulatory binder and/or electronic files for new studies and maintaining regulatory binder and/or electronic files throughout the course of the study, filing/updating all required documents and ongoing training/certifications appropriately, overseeing training logs and delegation of duties logs, working with study coordinator to ensure completion prior to enrollment and ongoing accurate maintenance throughout the study, maintaining documentation of all relevant training, preparing for and managing regulatory portion of industry study monitor visits, addressing all regulatory action items, creating informed consent documents for new studies and updating informed consent documents as needed throughout the study, facilitating process for investigator receipt and evaluation of external IND safety reports, and other duties as assigned.
Work location: Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.
Why join us: The University of Colorado Anschutz Medical Campus is the largest academic health center in the Rocky Mountain region at the forefront of transformative education, science, medicine, and healthcare. The campus includes the University of Colorado health professional schools, multiple centers, and institutes and two nationally ranked hospitals, UCHealth University of Colorado Hospital and Children's Hospital Colorado, which treat nearly 2 million patients each year. All interconnected, these organizations collaboratively improve the quality of patient care they deliver, research they conduct and health professionals they train.
Why work for the University? We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: 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. There are many additional perks & programs with the CU Advantage.
Equal employment opportunity statement: CU is an equal opportunity employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.
Qualifications: minimum qualifications: entry level: a bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution, intermediate level: a bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution 1 year professional experience in a clinical research setting with regulatory responsibilities, senior level: a bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution 2 years professional experience in a clinical research setting with regulatory responsibilities. Substitution: a combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. Condition of employment: willing and able to work occasional extended hours to meet work location needs. Preferred qualifications: experience working with principal investigators (PIs), 1 year project management experience, 3 years of regulatory experience, IRB experience (COMIRB or central IRB, such as WCG or Advarra), protocol writing, experience with University of Colorado/UCHealth systems (Colorado Multiple Institutional Review Board, UCHealth Research Administration, Oncore, InfoED, and Neurology NeuroCRAFT, Veeva). Experience with clinical trial management systems and web-based protocol submission systems. Experience with administrative duties, such as drafting documents and correspondence, preparing reports, proofreading, operating general office equipment (i.e. copy machine, fax machine, scanner).
How to apply: for full consideration, please submit the following document(s): a letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position, curriculum vitae / resume, three to five professional references, including name, address, phone number (mobile number if appropriate), and email address. Questions should be directed to: Neurology-hr@cuanschutz.edu. Screening of applications begins: applications will be accepted until finalists are identified, but preference will be given to complete applications received by August 1, 2025. Those who do not apply by this date may or may not be considered. Anticipated pay range: the starting salary range (or hiring range) for this position has been established as entry: $52,860-$67,239, intermediate: $57,525-$73,171, senior: $62,189-$79,104. The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total compensation calculator: ADA statement: the University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu. Background check statement: the University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees. Vaccination statement: CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.