OCRST IIT Regulatory Affairs Coordinator (Open-Rank)

OCRST IIT Regulatory Affairs Coordinator (Open-Rank)

OCRST IIT Regulatory Affairs Coordinator (Open-Rank) - 39656 University Staff Description

University of Colorado Anschutz Medical Campus

Department: Cancer Center

Working Title: OCRST IIT Regulatory Affairs Coordinator (Open-Rank)

Position #: 00696270 - Requisition #: 39656Job Summary:

The Cancer Center Oncology Clinical Research Support Team (OCRST) is responsible for providing central management and oversight for Investigator-Initiated Trials (IITs) at the CU Cancer Center. The Regulatory Affairs Coordinator (RAC) works with investigators and OCRST members in the development and implementation of IITs. This position is responsible for completing regulatory start up and maintenance tasks. The position will also be responsible for submissions to the Food and Drug Administration (FDA), with heavy emphasis on Investigator New Drug applications, but sometimes includes device submissions, as required for IITs. This position communicates appropriately and effectively with Principal Investigators, study investigators, other team members, and regulatory bodies such as FDA, Colorado Multiple Institutional Review Board (COMIRB), the Protocol Review & Monitoring System (PRMS), the IND/IDE Office, and UCHealth Research Administration (UCH-RA). Thus, outstanding customer service skills and participating in ongoing efforts to improve regulatory practices, procedures, and workflows is essential.

Key Responsibilities:

:

• Ensures compliance with institutional, state, federal, and drug/device or financial partners' regulations.
• Serves as regulatory contact person for IITs and meets with Principal Investigators as well as in-house staff for review of regulatory records.
• Assists Principal Investigators and Clinical Project Coordinator(s) in the development of the protocol and subsequent amendments for IITs to ensure standardization and adherence to University and Cancer Center, FDA and GCP policies, and guidelines for IITs.
• Drafts and maintains FDA Forms (e.g., 1571, 1572, 3674), Financial Disclosure Forms or other regulatory documents as requested by OCRST Regulatory Affairs Manager or RACs.
• Drafts and maintains IND applications/IDE submissions to FDA and correspond with agency as needed.
• Writes clear and accurate consent/HIPAA documents.
• Completes required applications, forms/documents for submission to regulatory agencies, including COMIRB, PRMS, and other regulatory bodies as required.
• Maintains regulatory documentation for the lifetime of study.
• In collaboration with Clinical Project Coordinator, compiles summary of changes document and other necessary documents for submission of protocol amendments to study/support sponsor and/or regulatory bodies for review and approval.
• Prepares and maintains the regulatory binder for review by monitors and auditors, including preparation for monitoring/auditing visits and assists with resolution of regulatory queries.
• Provides guidance to clinical teams for Unanticipated Problem (UAP) or Serious Adverse Event (SAE) reporting.
• Works closely with multiple study/support sponsors' web portals to:
  • Download safety updates and compile for PI review
  • Download study template documents and pharmacovigilance documents (i.e., Investigator's Brochure)
  • Upload study approval documents
• Compiles and submits study documents or progress reports to funding partners as required, independently completes, and submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the Cancer Center for assigned projects.
• Serves as back up coverage during RAC absences.
• Collects essential documents from participating trial sites and participates in regulatory communication for single site clinical trials.
• Updates OnCore and/or eReg with regulatory review information, documents, or other information in accordance with Standard Operating Procedures (SOPs), guidance documents, or work instructions.

Regulatory Affairs Coordinator Level II Duties (Intermediate Professional):

• Adheres to and conducts all duties related to Regulatory Affairs Coordinator Level I.
• Independently manages and provides support to more complex, higher acuity, or multi-site research studies.
• Participates in onboarding and training activities for new members of the Regulatory team; serves as back up coverage during team absences.
• Manages essential document collection and site regulatory communication for single site and multi-center clinical trials.
• Maintains site regulatory communication for multi-center clinical trials.
• Recommends and drafts enhancements to IIT Team SOPs, guidance documents, or other tools/templates pertinent to regulatory activities.
• Participates with OCRST Regulatory Affairs Manager and staff in discussions and activities to identify and implement ways to improve regulatory practices, procedures, and workflows.

Regulatory Affairs Coordinator Level III Duties (Senior Professional):

• Adheres to and conducts all duties related to Regulatory Affairs Coordinator Level I and Level II.
• Creates and maintains Trial Master File for applicable trials. Provides guidance and support to external sites during start up process to ensure timely filing of all regulatory requirements.
• Assists in development of Cancer Center SOPs, guidance documents, work instructions, and process workflow for IITs.
• Assists OCRST Regulatory Affairs Manager with resolving issues by utilizing independent judgement, discretion, creativity and analytical thinking.
• Collaborates with OCRST Regulatory Affairs Manager and staff to identify and implement ways to improve regulatory practices, procedures, and workflows.
• Acts as OCRST representative in Cancer Center initiatives and willingly accepts additional responsibilities and duties as assigned by management.
• Delegates tasks appropriately to student worker and/or Regulatory Affairs Coordinator I and II, oversees work performed on delegated tasks.
• Acts as mentor to and participates in planning for and onboarding activities for new members of the Regulatory Affairs team.
• Problem solves with other Regulatory Affairs Coordinators and Regulatory Manger when issues arise and collaborates with OCRST Regulatory Affairs Manager to define training and onboarding requirements and plans for new staff.
• Presents educational topics for initial or refresher training as part of new hire onboarding and at team meetings.

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 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/e mployee-services/benefits-wellnessQualifications:

Minimum Qualifications:

Regulatory Affairs Coordinator Level I (Entry Professional)

• Bachelor's Degree focused in Health Sciences (e.g., Pharmacy, Public Health, Nursing), Life Sciences (e.g. Biology, Chemistry, Physiology), Law, or related fields of study.
• Substitution: Work experience in a related field can substitute for the Bachelor's degree on a year for year basis.

Regulatory Affairs Coordinator Level II (Intermediate Professional):

• Bachelor's Degree focused in Health Sciences (e.g., Pharmacy, Public Health, Nursing), Life Sciences (e.g. Biology, Chemistry, Physiology), Law, or related fields of study.
• One (1) or more years of research, regulatory, or compliance experience.
• Substitution: Work experience in a related field can substitute for the Bachelor's degree on a year for year basis.
• ACRP, SOCRA, or RAC certification within one year of hire is required.

Regulatory Affairs Coordinator Level III (Senior Professional):

• Bachelor's Degree focused in Health Sciences (e.g., Pharmacy, Public Health, Nursing), Life Sciences (e.g. Biology, Chemistry, Physiology), Law, or related fields of study.
• Two (2) or more years of research, regulatory, or compliance experience with at least one (1) year regulatory or compliance experience in clinical research.
• Substitution: Work experience in a related field can substitute for the Bachelor's degree on a year for year basis.
• ACRP, SOCRA, or RAC certification is required. Maintenance of this certification is required.

Applicants must meet minimum qualifications at the time of application.

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.

Preferred Qualifications:

• Understanding of medical terminology and technical writing experience.
• Oncology research and/or academic center regulatory experience.
• Experience with submissions to IRBs, and/or the FDA for INDs or IDEs.
• Experience working with IITs.
• Experience handling and prioritizing detailed tasks and meeting deadlines.
• OnCore/eReg and/or InfoEd experience.

Knowledge, Skills and Abilities:

• Ability to problem-solve and multi-task in high volume settings.
• Understanding of research standards as set forth by FDA, ICH, OHRP, UCH, UCD and NCI.
• Self-motivated and directed, with keen attention to detail.
• Ability to work independently.
• Excellent communication skills both written and verbal.
• Proficient in Microsoft systems, especially Teams, Word, Excel, and PowerPoint.

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 (only use if a cover letter is necessary)
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: Stephanie Hill, stephanie.hill@cuanschutz.eduScreening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by April 23, 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

• Entry - $50,996-$64,867
• 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: http://www.cu.edu/node/153125Equal 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.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.

Application Materials Required: Cover Letter, Resume/CV, List of References Job Category
: Research Services Primary Location
: Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 20066 - SOM-U of Colo Cancer Center Schedule
: Full-time Posting Date
: Apr 17, 2026 Unposting Date
: Ongoing Posting Contact Name: Stephanie Hill Posting Contact Email: stephanie.hill@cuanschutz.edu Position Number: 00696270

To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=39656&lang=en

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