Regulatory Manager

University of Colorado•Aurora, CO

1d•Hybrid

About The Position

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%25 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. · 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 oversees 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 directs process improvements, as needed · Standardize regulatory education and knowledge across the CCTO to continuously improve study compliance

Requirements

Bachelor’s degree from an accredited institution with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment.
A combination of closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.
A minimum of 5 years of clinical research experience
A minimum of 5 years of Regulatory experience. This can be included in the 5 years of experience above
A minimum of 2 years of personnel management experience. This can be included in the 5 years of experience above.
Current Biomedical, HIPAA and GCP training (must have within 30 days of hire)
Current Clinical Research Certification (CCRC, CCRA, CCRP) OR eligible and willing to sit for next exam; must have certification within one year of employment. Failure to complete the certification requirement within one year may be cause for termination.
Excellent interpersonal communication, organizational skills, and ability to problem-solve and multi-task.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Understands the phases and concepts of clinical trials and the overall philosophies of conducting National Clinical Trials Network (NCTN) research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.
Knowledge of research study budgets.
Understanding of computer systems (specifically MS Office Suite, Adobe and Advarra OnCore) and ability to work efficiently within various applications. Examples of work include working within Advarra OnCore, and Advarra eReg to perform regulatory tasks and/or develop guidelines for use of computer systems.
Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials.
Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology.

Nice To Haves

Oncology regulatory experience
Experience with using Advarra OnCore for regulatory tasks (for example, enttering IRB approvals, uploading approved documents, re-consent required functionality)
Experience working simultaneously with various sponsors and studies in multiple phases
Experience working in an academic medical setting
Experience teaching, precepting, and mentoring employees to regulatory and clinical research.
Experience managing a remote team or working in a remote/hybrid environment

Responsibilities

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 oversees 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 directs process improvements, as needed
Standardize regulatory education and knowledge across the CCTO to continuously improve study compliance