Job Summary

The Clinical Research Compliance Manager is responsible for ensuring all cancer related clinical research at Huntsman Cancer Institute (HCI) is conducted according to the highest quality standards and in compliance with local, state and federal regulations. The Clinical Research Compliance Manager will ensure proper oversight of all Investigator Initiated Trials (IIT), as well as non-IIT studies conducted at HCI. The Clinical Research Compliance Manager will provide consistent leadership as well as operational and general oversight of the Research Compliance Office monitoring, audits, and quality assurance reviews to ensure competent and standardized practices that are compliant with all institutional and regulatory requirements. The position reports to the Director of Research Compliance Office and collaborates with partner departments including the Clinical Trials Office, Population Science Trials Office, Institutional Review Board, Office of Sponsored Projects, Office of General Counsel, etc. This position is eligible for hybrid work, partially remote, partially in an office located at HCI.

Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve - which includes Idaho, Montana, Nevada, Utah, and Wyoming - with impact worldwide.

In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute's mission and this position.

Responsibilities

Essential Functions

1. Collaborates with key research leadership, employees, physicians, members of the Institutional Review Board (IRB) and research study sponsors to identify, research, investigate and resolve research-related compliance issues by serving as an internal expert and advisor in clinical research compliance matters
2. Leads day to day operations of the Research Compliance Office programs including monitoring, audits and quality assurance reviews
3. Provides oversight and direction for the Clinical Site Monitors, Clinical Site Auditors, and Data Management staff
4. Supports the Data and Safety Monitoring Committee (DSMC) by ensuring the Research Compliance Office follows the NCI approved Data and Safety Monitoring Plan
5. Reviews and ensures the accuracy of comprehensive reports provided to the DSMC
6. Proactively identifies, prioritizes and implements policies and procedural changes to enhance efficiencies of research activities at HCI
7. Develops and implements methods, strategies, and standard operating procedures to ensure all compliance needs are met
8. Develop, coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues
9. Keeps current on new local and federal regulations, rules, revisions, and other industry standards that govern human subject research
10. Conducts for-cause and spot audits of clinical trials
11. Assists in internal and external audits of research activities
12. Collaborates on investigations of matters of suspected non-compliance with appropriate key stakeholders to determine the appropriate corrective and preventative action plan
13. Creates metrics to improve performance, efficiency and quality of research activities at HCI
14. Participates in projects as assigned to promote research compliance
15. Coordinates with Regulatory team when needed to address regulatory-related matters