Regulatory Affairs Coordinator

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. Specific duties may include writing accurate informed consent forms, submissions to applicable review committees (PRMS, IRB of record, UCHealth Research Administration), completion of Regulatory documents (Form 1572, Financial Disclosure forms), protocol amendment submissions and semi-annual or annual IRB continuing reviews.

Key Responsibilities:

• 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.
• Provides guidance to clinical teams for Unanticipated Problem (UAP) or Serious Adverse Event (SAE) reporting.
• Works with clinical team to ensure protocols amendments are moving through our complex process as quickly as possible.
• Writes or revises clear and accurate consent/ HIPAA documents.
• Completes consents, applications, and other required forms as per the applicable Institutional Review Board (IRB).
• Submits, tracks and processes protocol amendments for National Clinical Trials Network (NCTN) studies within the required 30-day period (for CIRB)
• Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado Cancer Center. This may include, but is not limited to, the following:
  • Colorado Multiple Institutional Review Board (COMIRB)
  • Western Copernicus Group Institutional Review Board (WCG IRB, formerly WIRB)
  • NCI Central Institutional Review Board (CIRB)
  • Protocol Review and Monitoring System (PRMS)
  • Hospital Research Support Services (UCH-RSS)
  • University of Colorado Hospital Clinical Trials Office (CTO)
• Completes and submits continuing reviews, amendments, and other protocol-specific documents.
• Completes and submits accurate federal forms, consents, HIPAA Authorizations, and obtains required approvals specific to the Denver VA medical Center.
• Navigates applicable NCTN websites. This may include Clinical Trials Support Unit (CTSU), Southwest Oncology Group (SWOG) and NRG Oncology (NSABP, RTOG, GOG).
• Updates OnCore with regulatory documents and dates.
• Informs clinical team(s) when approved documents are ready for use.

Additional Duties for RAC II

• Assists in the completion of initial Institutional Biosafety (IBC) applications.
• Provides shadowing of daily tasks for new members of the Regulatory Affairs team.
• Serves as back up coverage during RAC absences.
• Assists in document collection and site regulatory communication for multi-center clinical trials.

Additional Duties for RAC III

• Potentially meets with representatives from Food and Drug Administration (FDA) for review of records.
• Completes required documents for all submissions specific to trials requiring Institutional Biosafety Committee (IBC) oversight.
• Completes required documents for all submissions specific to trials requiring FDA approval.
• Assists with training for new members of the Regulatory Affairs team.
• Serves as back up coverage during RAC absences.
• Collects documents and site regulatory communication for multi-center clinical trials.

Work Location:

Remote - this role is eligible to work remotely, but the employee must be in the United States.

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 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.

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

Diversity and Equity:

At the University of Colorado Cancer Center (CU Cancer Center), we deem diversity in thought, perspective, lived experiences, and backgrounds to be essential for understanding and providing world-class health and cancer care to our diverse patient populations. We are, therefore, committed to the intentional development of a diverse, equitable, inclusive, and respectful academic community and workplace. We actively encourage individuals of all races, religions, national origins, genders, gender expressions, sexual orientations, ages, as well as veterans and individuals with disabilities to apply for positions at the CU Cancer Center.

If you are an applicant with a disability, the University will provide reasonable accommodations throughout the employment application process. Please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu to request an accommodation in accordance with the Americans with Disability Act.

Qualifications:

Minimum Requirements 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: Work experience in a related field may substitute for the degree on a year for year basis.

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 Requirements 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: Work experience in a related field may substitute for the degree on a year for year basis.

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 Requirements 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: Work experience in a related field may substitute for the degree on a year for year basis.

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

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

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

Knowledge, Skills and Abilities

• Ability to problem solve and multi-task.
• Ability to work independently.
• Ability to think critically and organize tasks for prioritization.
• Basic understanding of research specific to Human Subject Research protection, Good Clinical Practice and IRB requirements.
• Good command of the English language, both written and verbal.
• Proficient in Windows, MS Word, Excel, PowerPoint.
• Excellent customer service skills.

Additional Skills for RAC II

• Understanding of research standards as set forth by FDA, OHRP, UCH, UCD and NCI.

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: Jamie Gray, jamie.gray@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by 02/24/25 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:

RAC I (Entry): $50,996 - $64,867

RAC II (Intermediate): $55,496 - $70,590

RAC III (Senior): $59,996 - $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: http://www.cu.edu/node/153125

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@ucdenver.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.