Regulatory Affairs Professional (Open Rank: Intermediate - Senior)

Job Summary:

The Department of Neurology has an immediate opening for a full-time Regulatory Affairs Professional. The position will independently maintain and manage all IRB and regulatory processes for multi-site sponsored research studies relying on a central IRB as well as local IRB studies. 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 training UCD 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 regulatory team, subspecialty program managers, and clinical research coordinators.

Key Responsibilities:

• Facilitate completion of initial essential regulatory documents (FDA 1572, Financial Disclosure forms, PI signature pages, etc)

• Create/organize regulatory binder and/or electronic files for new studies and maintain regulatory binder and/or electronic files throughout the course of the study, file/update all required documents and ongoing training/certifications appropriately

• Oversee training logs and delegation of duties logs, working with study coordinator to ensure completion prior to enrollment and ongoing accurate maintenance throughout the study

• Maintain documentation of all relevant training

• Prepare for and manage regulatory portion of industry study monitor visits, addressing all regulatory action items

• Create informed consent documents for new studies and update informed consent documents as needed throughout the study

• Facilitate process for investigator receipt and evaluation of external IND safety reports

• 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.

Qualifications:

Minimum Qualifications:

Applicants must meet minimum qualifications at the time of hire.

Intermediate Professional

• 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

• Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

• 1 year of professional level regulatory experience (central IRB or local IRB)

Senior Professional

• 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

• Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis.

• 2 years of professional level regulatory experience (central IRB or local IRB)

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)

Knowledge, Skills and Abilities:

• Basic knowledge of human subjects research regulations including: International Council for Harmonization GCP, Code of Federal Regulations (CFR), Office for Human Subjects Research Protections (OHRP) and other regulatory requirements related to the conduct of clinical trials

• Applicants must have great attention to detail and enjoy administrative, task-based work

• Exceptional organizational skills and the ability to multi-task, plan work processes and prioritize in order to ensure that the deadlines are consistently and reliably met. Comfortable working on many projects at the same time

• Knowledge of, and the ability to become fully competent in computer programs and web-based reporting systems essential to the core functions of the position

• Ability to work independently, exercise sound judgement, identify and set priorities for self and others

• Ability to be self-motivated and exercise a professional attitude in order to work effectively in independent and team situations

• Ability to communicate effectively with all levels of personnel in the department, and all University departments, offices and programs. Strong written communication skills

• Strong analytical and problem solving skills

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. 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:

Immediately and continues until position is filled. For best consideration, apply by December 1, 2025.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as

• Intermediate: $55,495-$70,590

• Senior: $59,995 - $76,314

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

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.

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.