Regulatory Manager

University of Colorado Anschutz Medical Campus

Department: Cancer Center

Working Title: Regulatory Manager

Position #: 00806499 – Requisition #: 39011

Job Summary:

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

 Examples of Work Performed

50% Leadership, Compliance, and Process Improvement

·       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.