Research Services Clinical Sciences Regulatory Program Manager

Job Summary:

The Regulatory Program Manager (PM) for the Airway, Trauma, Lung injury, and Sepsis (ATLAS) Research Program at the University of Colorado School of Medicine will play a crucial role in developing, executing, and overseeing regulatory and technical documents and processes for ongoing and upcoming clinical trials within ATLAS. The Regulatory PM will manage regulatory documents, including Institutional Review Board (IRB) protocols and all associated documents, Food and Drug Agency (FDA) documents, and second-level reviewed documents for the Department of War OHRO. This position will work closely with lead project coordinators, Principal Investigators (PIs), and ATLAS Leadership. The Regulatory PM may also assist faculty and PIs with developing regulatory aspects of grant proposals. In some instances, particularly for randomized controlled trials and multi-center trials, the Regulatory PM will support the structuring and writing of critical elements to convey the work performed within ATLAS. The Regulatory Program Manager is expected to be knowledgeable in areas of regulatory components of clinical trials from study start to study closure. This position oversees regulatory strategy and compliance for clinical trials in the ATLAS Research Program.

Key Responsibilities:

* Works with ATLAS investigators and collaborators to develop, write, and revise regulatory and ethics sections of grant proposals and scientific manuscripts

* Provides feedback to investigators to improve clarity and logic of IRB submissions

* Works with project lead(s) to execute IRB submissions (initial, amendments, continuing reviews, UAPs, and study closure)

* Oversees and tracks all IRB submissions

* Manages the development, submission, and renewal of all second-level reviewed documents for the Department of War OHRO, as applicable

* Consults with investigators in responding to questions and requests for revisions to proposal documents, IRB and OHRO protocol submissions

* Ensures program/project compliance with FDA and other regulatory bodies

* Development of IND/IDE applications, amendments, and annual reports for FDA submission in conjunction with PIs

* Provides expertise to associated projects requiring Exception from Informed Consent (EFIC)

* Works with project lead(s) to complete all AE/SAE reporting according to IRB and FDA regulations and timelines

* Assists in the development of protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs)

* Works with investigators to develop reports and effectively communicate status and findings to stakeholders

* Completes internal regulatory audits to assess compliance and areas of improvement

* Prepares for monitoring visits, in conjunction with the project lead

* Assists with other duties associated with the ATLAS Research Program, as appropriate

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 4 days per week on campus and as needed for in-person meetings.

Why Join Us:

The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty, and staff of diverse backgrounds.

This is an in-person position within the ATLAS lab, which offers a unique career and growth opportunity to serve as an integral member of a highly productive, collaborative, and vibrant research group conducting impactful health research in the care of acutely ill and injured patients. The diverse and complex patient population provides a rich learning environment and opportunities to expand the candidate's skillset across several research projects (including clinical trials and observational trials). The candidate will also be exposed to a like-minded research community to help enrich skills and enhance career growth. The ATLAS lab aims to advance solutions to the greatest challenges in acute care by leading transformative clinical trials. We are interested in candidates that have/want a direct connection to advancing medical knowledge and evidence-based care that can impact the lives of patients.

Outside the ATLAS lab environment, the candidate will be part of the larger University of Colorado Anschutz Medical Campus community. CU Anschutz is a prestigious public education, clinical and research academic institution serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $650 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

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:

• Bachelor's degree in any field

* Four (4) years of professional experience managing documents for IRB submissions, or working as a review officer for an IRB or OHRO (pre-clinical/wet lab experience does not apply)

* Experience with IND/IDE FDA submission preparation, management, and oversight

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

* Bachelor's degree in science or health related field

* Five (5) years of professional experience developing and managing documents for IRB submissions, or working as a review officer for an IRB or OHRO

* Experience reviewing protocols at an institution of higher education, large hospital, or contract/academic research organization (CRO/ARO)

* Experience with Department of War OHRO

* Experience executing studies requiring Food and Drug Administration (FDA) oversight

* Experience working on projects requiring Exception from Informed Consent (EFIC)

* Prior experience managing regulatory components as the coordinating center for single- and multi-center clinical trials (e.g. IRB)

Knowledge, Skills and Abilities:

* Strong project management skills and experience within a complex and diverse environment

* Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP)

* Demonstration of strong analytical and problem-solving skills

* Ability to communicate effectively, both in writing and orally

* Ability to establish and maintain effective working relationships with employees at all levels and disciplines throughout the institution

* Able to organize multiple tasks with varying deadlines

* Outstanding customer service skills

* Able to quickly acquire working knowledge regarding a variety of scientific/medical fields

* Ability to interpret and master complex research protocol information

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.

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: Carolyn Hamburg, emed.humanresources@ucdenver.edu

Screening of Applications Begins:

Immediately and continues until the position is filled. For best consideration, apply by November 1, 2026.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as HIRING RANGE ($74,627 - $100,000).

The above salary 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.