Research Services Clinical Sciences Regulatory Program Manager

University of Colorado•Aurora, CO

10d•$74,627 - $100,000•Hybrid

About The Position

The Regulatory Program Manager for the Airway, Trauma, Lung injury, and Sepsis (ATLAS) Research Program at the University of Colorado School of Medicine develops, executes, and oversees regulatory and technical documents and processes for ongoing and upcoming clinical trials. The role manages Institutional Review Board (IRB) protocols and related documents, Food and Drug Administration (FDA) documents, and second-level reviewed documents for the Department of War OHRO. It works closely with project coordinators, Principal Investigators, and ATLAS leadership, and may assist faculty and PIs with regulatory aspects of grant proposals. For some randomized controlled and multi-center trials, the position also supports structuring and writing key elements that describe work performed within ATLAS. The role oversees regulatory strategy and compliance throughout clinical trials, from study start through closure.

Requirements

Bachelor’s degree in any field.
Four 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.
Strong project management skills and experience in a complex and diverse environment.
Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
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 across disciplines.
Ability to organize multiple tasks with varying deadlines.
Outstanding customer service skills.
Ability to quickly acquire working knowledge of a variety of scientific and medical fields.
Ability to interpret and master complex research protocol information.
Must be legally authorized to work in the United States without requiring sponsorship; sponsorship or employment authorization will not be provided.

Nice To Haves

Bachelor’s degree in a science or health-related field.
Five 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 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, such as IRB components.

Responsibilities

Develop, write, and revise regulatory and ethics sections of grant proposals and scientific manuscripts with ATLAS investigators and collaborators.
Provide investigators with feedback to improve the clarity and logic of IRB submissions.
Work with project leads to execute initial IRB submissions, amendments, continuing reviews, UAPs, and study closures.
Oversee and track all IRB submissions.
Manage the development, submission, and renewal of applicable second-level reviewed documents for the Department of War OHRO.
Consult with investigators on questions and revision requests regarding proposal documents and IRB and OHRO protocol submissions.
Ensure program and project compliance with FDA and other regulatory bodies.
Develop IND/IDE applications, amendments, and annual reports for FDA submission in conjunction with PIs.
Provide expertise to projects requiring Exception from Informed Consent (EFIC).
Work with project leads to complete AE/SAE reporting according to IRB and FDA regulations and timelines.
Assist in developing protocol-specific systems and documents, including process flows, training manuals, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs).
Work with investigators to develop reports and communicate status and findings effectively to stakeholders.
Complete internal regulatory audits to assess compliance and identify areas for improvement.
Prepare for monitoring visits in conjunction with the project lead.
Assist with other duties associated with the ATLAS Research Program, as appropriate.