Regulatory Affairs Coordinator (Open Rank)

University of Colorado Anschutz; Aurora (CO); Hybrid; USD 53,000 - 79,000; Full time

Benefits offered by this job

Hybrid schedule

Excellent benefits

Tuition benefit

ECO Pass

Job summary

The University of Colorado Anschutz Medical Campus is seeking a Regulatory Affairs Coordinator to manage regulatory submissions, document preparation, and communication across clinical trial teams. This role handles Form 1572, disclosures, continuing reviews, amendments, and safety reporting with a focus on GCP, FDA regulations, and applicable policies.

Hybrid work 3 days per week on campus with in-person meetings as needed.

Qualifications

• Education: Bachelor’s Degree in any field from an accredited college or university.
• Work Experience: One or more years of professional medical, clinical and/or research experience.
• Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year-for-year basis.
• An advanced degree may be substituted for experience on a year-for-year basis if the degree is in a field of study directly related to the work assignment.
• Required for RAC I: Condition of Employment - 5 CEUs

Responsibilities

• Serves as regulatory contact person for ongoing clinical research studies
• Provides guidance to clinical teams for Unanticipated Problem (UAP) or Serious Adverse Event (SAE) reporting
• Works with clinical team to ensure protocols move through our complex process quickly
• Drafts or revises informed consent and HIPAA documents
• Prepares, submits, and tracks regulatory applications, amendments, continuing reviews, consent documents, and other required study documentation
• Reviews, submits, and files CIOMS, SUSARS, Line-listings, IND and other safety reports as needed
• Coordinates submissions to applicable regulatory and institutional review bodies and ensures compliance with required timelines and approval requirements

Skills

Attention to detail

Communication skills

Regulatory knowledge

Time management

Problem solving

Planning & organizing

Education

Bachelor's Degree in any field

Advanced degree (Masters/Doctorate) in related field

Tools

MS Outlook

MS Word

MS Excel

Job description

University of Colorado Anschutz Medical Campus

Department: Cancer Center - Cancer Clinical Trails Office (Regulatory Team)

Working Title: Regulatory Affairs Coordinator (Open Rank)

Position #: 00683036 - Requisition #: 41584

Job Summary:

As an important member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position works with Phase I-IV industry sponsored (Pharmaceutical), Cooperative Group (NCTN) and/ or Investigator initiated clinical trials in accordance with FDA Regulations, Good Clinical Practice (GCP) and applicable guidelines or policies. The successful candidate will be responsible for providing regulatory management and oversight for clinical trials, including drafting informed consent documents; preparing and submitting all study-related regulatory documents (Form 1572, Financial Disclosure forms, continuing review, amendments) to applicable review committees (PRMS, IRB of record, UCHealth Research Administration); and supporting clinical teams with the development and submission of Unanticipated Problems.

In order to succeed in this position, the individual must be detail-oriented and able to demonstrate superior organizational skills in order to successfully track multiple tasks occurring in parallel. This incumbent must be self-motivated to complete tasks quickly and within set deadlines. This position is the 'hub' of communication between and internal stakeholders so superior oral and written communication skills are required.

Key Responsibilities for All Levels

• Serves as regulatory contact person for ongoing clinical research studies
• Provides guidance to clinical teams for Unanticipated Problem (UAP) or Serious Adverse Event (SAE) reporting
• Works with clinical team to ensure protocols are moving through our complex process as quickly as possible
• Drafts or revises informed consent and HIPAA documents
• Prepares, submits, and tracks regulatory applications, amendments, continuing reviews, consent documents, and other required study documentation
• Reviews, submits, and files CIOMS, SUSARS, Line-listings, IND and other safety reports as needed
• Coordinates submissions to applicable regulatory and institutional review bodies and ensures compliance with required timelines and approval requirements. This may include, but not limited to:
• Colorado Multiple Institutional Review Board (COMIRB)
• Western Copernicus Group Institutional Review Board (WCG IRB)
• NCI Central Institutional Review Board (CIRB)
• Protocol Review and Monitoring System (PRMS)
• Navigates applicable NCTN websites:
• Clinical Trials Support Unit (CTSU)
• Southwest Oncology Group (SWOG)
• NRG Oncology (NSABP, RTOG, GOG)
• Maintains regulatory documentation and study milestones in institutional tracking systems (Advarra OnCore and eRegulatory management system)
• Serves as back up coverage during RAC absences

Additional Duties for RAC II

• Assists in the completion of initial Institutional Biosafety (IBC) applications
• Assists in the completion of Single-Patient IND (sIND) processes and Expanded Access Programs
• Provides shadowing of daily tasks for new members of the Regulatory Affairs team

Additional Duties for RAC III

• Completes all required documentation for submissions specific to trials requiring Institutional Biosafety Committee (IBC) oversight
• Completes all required documentation for Single-Patient IND (sIND) processes and Expanded Access Programs
• Assists with training for new members of the Regulatory Affairs team
• Potentially meets with representatives from Food and Drug Administration (FDA) for review of records

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 Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "prevent and conquer cancer. Together." At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education."

Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.

Why work for the University?

We have AMAZING benefits and offerexceptional 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.

To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness

Qualifications:

Minimum Qualifications for RAC I

• Education: Bachelor's Degree in any field from an accredited college or university.
• Work Experience: One or more years of professional medical, clinical and/or research experience.
• Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.
• An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
• Required for RAC I: Condition of Employment - Individual must obtain and track continuing education regardless of whether they have an additional certification (required annual levels): RAC I - 5 CEUs

Minimum Qualifications for RAC II

• Education: Bachelor's Degree in any field from an accredited college or university
• Work Experience: Two or more years of professional research experience (One year must be oncology and/or academic regulatory experience).
• Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.
• An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
• Required for RAC II: Condition of Employment - Individual must obtain and track continuing education regardless of whether they have an additional certification (required annual levels): RAC II - 10 CEUs

Minimum Qualifications for RAC III

• Education: Bachelor's Degree in any field from an accredited college or university.
• Work Experience: Three or more years of professional regulatory experience. At least two years of regulatory experience in oncology or a complex academic setting is required.
• Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.
• An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
• Required for RAC III: Condition of Employment - Individual must obtain and track continuing education regardless of whether they have an additional certification (required annual levels): RAC III - 15 CEUs

Applicants must meet minimum qualifications at the time of application.

Preferred Qualifications for RAC I

• At least 1 year of Regulatory experience.
• Experience working with NCI, Industry, and Investigator Initiated clinical trials.
• Experience working in an academic and/or medical environment.

Additional Preferred Qualifications for RAC II

• Experience with submissions to the FDA for IND or IDE.

Additional Preferred Qualifications for RAC III

• Working knowledge of FDA Regulations and OHRP Guidance - how they apply to oncology clinical trials.
• Professional Research certification (one of the following):
  • CCRC - Certified Clinical Research Coordinator
  • CCRP - Certified Clinical Research Professional
  • CCRA - Certified Clinical Research Associate

Conditions of Employment:

• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.
• This positionisrequiredto worka hybrid schedule (on-campus, 3 days per week)

Knowledge, Skills and Abilities:

• Analytical Skills - Ability to interpret and master complex research protocol information.
• Attention to Detail - Excellent attention to detail and ability to interpret and master complex research protocol information
• Complex Problem Solving - Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
• Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.
• Interpersonal Skills- Ability to establish and maintain effective working relationships with employees at all level; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality.
• Customer Service- Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.
• Adaptability- Adapts quickly to change and is able to manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; is able to work independently and as part of a team.
• Planning and Organizing - Sets priorities, anticipates obstacles when planning ahead, manages time effectively to accomplish tasks.
• Technical Skills- Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology.

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by November 6, 2026. 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 HIRING RANGE (minimum - 40th posting max).

Level I: $52,860 - $67,239

Level II: $57,525 - $73,171

Level III: $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: http://www.cu.edu/node/153125

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 [e-mail].

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.