Regulatory Affairs Coordinator (Open Rank: Entry/Level 1 Senior/Level 3)
Description
University of Colorado Anschutz Medical Campus
Department: Cancer Center
Working Title: Regulatory Affairs Coordinator (Open Rank: Entry/Level 1 - Senior/Level 3)
Position #: 00676884 - Requisition #: 36956
Job Summary:
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:
Why Join Us:
Why work for the University?
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
Qualifications:
Minimum Requirements for RAC I
Bachelor's Degree in any field from an accredited college or university.
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.
Condition of Employment - Required for RAC I:
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
Bachelor's Degree in any field from an accredited college or university
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.
Condition of Employment - Required for RAC II:
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
Bachelor's Degree in any field from an accredited college or university.
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.
Condition of Employment - Required for RAC III:
Individual must obtain and track continuing education regardless of whether they have an additional certification (required annual levels):
RAC III - 15 CEUs
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:
A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position (only use if a cover letter is necessary)
Curriculum vitae / Resume
Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address
Screening of Applications Begins:
Anticipated Pay Range:
Entry- $50,996-64,687
Intermediate- $55,495-70,590
Senior- $59,995-76,314
Equal Employment Opportunity Statement:
ADA Statement:
Background Check Statement:
Vaccination Statement:
Job Category
Primary Location
Schedule
Posting Date
Unposting Date
To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=36956&lang=en (https://apptrkr.com/6501517)
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Regulatory Affairs Coordinator (Open Rank: Entry/Level 1 - Senior/Level 3) - 36956 University Staff
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.
Remote - This role is eligible to work remotely, but the employee must be in the United States
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.We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:There are many additional perks & programs with the CU Advantage (https://apptrkr.com/get_redirect.php?id=6501517&targetURL=https://advantage.cu.edu/) .
Applicants must meet minimum qualifications at the time of application.
For full consideration, please submit the following document(s):Questions should be directed to: burlleen.hewitt@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=6501517&targetURL=burlleen.hewitt@cuanschutz.edu)
Applications will be accepted until finalists are identified, but preference will be given to complete applications received by June 4, 2025. Those who do not apply by this date may or may not be considered.
The starting salary range (or hiring range) for this position has been established asThe 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 (https://apptrkr.com/get_redirect.php?id=6501517&targetURL=http://www.cu.edu/node/153125)
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.
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 (https://apptrkr.com/get_redirect.php?id=6501517&targetURL=hr.adacoordinator@cuanschutz.edu)
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.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get\redirect.php?id=6501517&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . 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 (https://apptrkr.com/get\redirect.php?id=6501517&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Remote Department: U0001 -- Anschutz Med Campus or Denver - 20066 - SOM-U of Colo Cancer Center : Full-time : Aug 20, 2025 : Ongoing Posting Contact Name: Burlleen Hewitt Posting Contact Email: burlleen.hewitt@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=6501517&targetURL=burlleen.hewitt@cuanschutz.edu) Position Number: 00676884jeid-420258dab1ce6d49b910cb4f43dbbaf8
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.
