Manager, Clinical Research

Job Summary The Clinical Research Compliance Manager is responsible for ensuring all cancer-related clinical research at Huntsman Cancer Institute (HCI) is conducted in accordance with the highest quality standards and in compliance with local, state, and federal regulations. The manager oversees Investigator Initiated Trials (IIT) and non-IIT studies, provides leadership and operational oversight of the Research Compliance Office, and monitors audits and quality assurance reviews to ensure compliance with institutional and regulatory requirements. The position reports to the Director of the Research Compliance Office and collaborates with the Clinical Trials Office, Population Science Trials Office, Institutional Review Board, Office of Sponsored Projects, Office of General Counsel, and other departments. This position is eligible for hybrid work, partially remote and partially on-site at HCI. Responsibilities Collaborate with research leadership, employees, physicians, IRB members, and sponsors to identify, investigate, and resolve research-compliance issues, serving as an internal expert and advisor. Lead day-to-day operations of the Research Compliance Office, including monitoring, audits, and quality assurance reviews. Provide oversight and direction for Clinical Site Monitors, Clinical Site Auditors, and Data Management staff. Support the Data and Safety Monitoring Committee (DSMC) by ensuring the Research Compliance Office follows the NCI-approved Data and Safety Monitoring Plan and provide accurate reports to the DSMC. Proactively identify, prioritize, and implement policies and procedural changes to enhance research efficiencies at HCI. Develop and implement methods, strategies, and SOPs to meet all compliance needs. Coordinate and deliver educational and training programs to raise compliance awareness. Stay current on new local and federal regulations, rules, and industry standards governing human subject research. Perform for-cause and spot audits of clinical trials and assist in internal and external audits. Collaborate on investigations of suspected non-compliance and develop corrective and preventative action plans. Create metrics to improve performance, efficiency, and quality of research activities at HCI. Participate in projects that promote research compliance. Coordinate with the Regulatory team when necessary to address regulatory-related matters. Problem Solving The incumbent uses federal, institutional guidelines and requirements to complete submission of regulatory documents, negotiates with university research committees and sponsors to ensure full compliance and communication. The role prioritizes workload, establishes systems, and coordinates across departments to meet regulatory objectives, resolving issues and making recommendations for correction. Work Environment and Frequency Nearly continuously in an office environment. Physical Requirements and Frequency Nearly continuously: sitting, hearing, listening, talking. Often: repetitive hand motion (such as typing), walking. Minimum Qualifications Bachelor’s degree in a related field or equivalent (one year of education can be substituted for two years of related work experience). Four to six years of progressively responsible management experience. Demonstrated leadership in planning, directing employees, and managing processes. Master’s degree preferred. Preferences Three to five years of experience in research compliance or a similar auditing environment with GCP knowledge. Proficiency with electronic systems used to manage clinical trial data and safety reporting. Oncology and/or hematology research experience highly preferred. Strong working knowledge of FDA, OHRP, ICH GCP, and state/federal guidelines governing human subject research. Knowledge of the clinical development process for managing multiple projects and timelines. Strong attention to detail, prioritization, and deadline adherence. Initiative, independence, and task completion ability. Excellent oral and written communication and leadership skills. Proficiency in Microsoft Office applications and project-management tools. SOCRA or ACRP certification. Completion of supervisory training within one year of employment may be required. Additional Information This position may require a successful completion of a criminal background check and/or drug screen. EEO Statement Consistent with state and federal law, the University of Utah does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender or gender identity, pregnancy, pregnancy‑related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The University does not discriminate in admission and employment. Requests for Reasonable Accommodation On request, reasonable accommodations in the application process will be provided to individuals with disabilities. #J-18808-Ljbffr