University of Colorado Anschutz Medical Campus

Department: Emergency Medicine

Job Title: Research Services Regulatory Compliance Program Manager

Position #:00853486 - Requisition #: 41185

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 manuscript
• Provides feedback to investigators to improve clarity and logic of IRB submission
• Works with project lead(s) to execute IRB submissions (initial, amendments, continuing reviews, UAPs, and study closure)
• Oversees and tracks all IRB submission
• 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 submission
• Ensures program/project compliance with FDA and other regulatory bodie
• Development of IND/IDE applications, amendments, and annual reports for FDA submission in conjunction with PI
• 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 timeline
• 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 stakeholder
• 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.

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 skill
• 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 deadline
• Outstanding customer service skill
• Able to quickly acquire working knowledge regarding a variety of scientific/medical field
• 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 addre

Questions should be directed to: Carolyn Hamburg, [email protected]

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.

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