Research Services Clinical Sciences Regulatory Program Manager

University of Colorado•Aurora, CO

3d•Hybrid

About The Position

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.

Requirements

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.
Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship and employment authorization for this position now or in the future.

Nice To Haves

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)
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

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