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 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 candidates 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.

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: work for the University

We haveAMAZINGbenefits 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.

Qualifications:

Minimum Qualifications:

• Bachelors 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:

Bachelors 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

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 ($74627 - $100000).

The above salary range represents the Universitys 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.

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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 .

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 othervaccine 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 addition if you work in certain research areas or perform certain safety sensitive job duties you must enroll in theoccupational health medical surveillance program.