Regulatory Manager

University of Colorado Anschutz Medical Campus

Department:
Cancer Center

Working Title: Regulatory Manager

Position #:  - Requisition #: 39011

The Regulatory Manager will collaborate with the CCTO Regulatory and Compliance Program Director to ensure efficiency and compliance within the program. The Regulatory Manager will be assigned primary areas of focus including 2 or more of the following:

• Regulatory projects associated with Trial Activation
• Regulatory projects associated with Electronic Systems
• Regulatory projects associated with Amendments
• Regulatory projects associated with Federally Funded Studies
• Regulatory aspects of Sponsor Affairs
• Study Maintenance

The Regulatory Manager collaborate with the CCTO Regulatory and Compliance Program Manager and Clinical Research Managers in establishing best practice recommendations for compliance, establishing quality assurance program(s) and implementing standard operating procedures to ensure high quality study conduct.

• Provide oversight, direction and leadership for all regulatory operations within the CCTO.
• Evaluate and operationalize Regulatory impact for integrating CCTO guidance documents/Cancer Center SOPs into regulatory workflow to bolster compliance and meet Cancer Center strategic goals.
• Lead evaluation of regulatory compliance with new sponsor, NCI, and/or FDA initiatives that include rolling out updates to document templates, guidance documents or SOPs as needed.
• Lead the implementation of new regulatory technologies such as Advarra eReg, UCHealth RECRUIT.
• Assess Regulatory impact of updates to the Biosafety application requirements and direct changes, as needed.
• Negotiate standard consent form language with preferred pharmaceutical company partners.
• Collaborate with the CCTO/COE Liaison to direct process improvements for non-English speaking research subjects and to ensure adherence to SOPs and applicable guidelines.
• Direct revisions to the CIRB Signatory Worksheet (boilerplate language) in collaboration with the Regulatory and Compliance Program Director.
• Engage with other Cancer Center research teams to streamline processes across the Cancer Center with the goal of reducing inconsistencies.
• Partner with Regulatory and Compliance Program Director to coordinate RAC team meetings, team trainings, and team building activities or delegates responsibility to team members as appropriate.
• Lead the preparation for external audits and FDA Inspections.
• Lead process to develop, implement and maintain CCTO Guidance documents or 'How To' documents with input from Regulatory Supervisors and CCTO Regulatory Compliance and Quality Program Manager.
• Oversee the development of standard practices for Regulatory department based on FDA Regulations and GCP guidelines and oversee implementation of practices.
• Provide input on University of Colorado Cancer Center SOPs by participating as a member of the Cancer Center SOP working group.
• Evaluate the Regulatory compliance impact of new Cancer Center and institutional programs and direct process improvements, as needed.
• Standardize regulatory education and knowledge across the CCTO to continuously improve study compliance.

Hybrid - This is not a remote position. This offer is contingent upon you working full-time, hybrid, on the Anschutz Medical Campus. In the event of departmental workload increase or special projects, you may be asked to report full-time on site until project completion.

The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "prevent and conquer cancer. Together."

At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education."

Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.

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
• Dental:
  Multiple plan options
• Additional Insurance:
  Disability, Life, Vision
• Retirement 401(a) Plan:
  Employer contributes 10% of your…