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