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 according to the highest quality standards and in compliance with local, state and federal regulations. The Manager oversees Investigator Initiated Trials (IIT) and non-IIT studies, providing leadership and operational oversight of the Research Compliance Office. The role ensures consistent monitoring, audits, and quality assurance reviews to maintain compliant practices across institutional and regulatory requirements. The position reports to the Director of the Research Compliance Office and collaborates with partner departments including the Clinical Trials Office, Population Science Trials Office, Institutional Review Board, Office of Sponsored Projects, and Office of General Counsel. This position is eligible for hybrid work, partially remote, partially in an office at HCI. Responsibilities Essential Functions: Collaborate with key research leadership, physicians, IRB members, and study sponsors to identify, investigate, and resolve research‑related compliance issues as an internal expert. Lead day‑to‑day operations of the Research Compliance Office programs 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. Review and ensure the accuracy of comprehensive reports provided to the DSMC. Proactively identify, prioritize, and implement policy and procedural changes to improve research efficiencies at HCI. Develop and implement methods, strategies, and standard operating procedures to meet all compliance needs. Coordinate and participate in educational and training programs to enhance compliance awareness. Keep current on new local and federal regulations, rules, revisions, and industry standards governing human subject research. Conduct for‑cause and spot audits of clinical trials. Assist in internal and external audits of research activities. Collaborate on investigations of suspected non‑compliance and develop corrective and preventative action plans. Create metrics to improve research performance, efficiency, and quality at HCI. Participate in projects to promote research compliance. Coordinate with the Regulatory team when needed to address regulatory‑related matters. Problem Solving This position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. The incumbent negotiates with university research committees and sponsors to ensure compliance and communication. The incumbent must prioritize workload and establish systems to achieve regulatory objectives, coordinating multiple departments and ensuring compliance with FDA, Good Clinical Practice, IRB, NIH, and other regulatory agency guidelines. Efforts are coordinated to resolve or recommend corrective actions to the Director and management team. Work Environment Nearly continuously: office environment. Physical Requirements Nearly continuously: sitting, hearing, listening, talking. Often: repetitive hand motion (such as typing), walking. Minimum Qualifications Bachelor’s degree in a related area 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. Background knowledge of the department’s area of specialization and demonstrated leadership skills in planning, directing employees and processes. Master’s degree in a related area is preferred. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined. Preferences 3–5 years working experience in research compliance, or a similar quality 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 regulations governing human subject research (FDA, OHRP, ICH GCP, state and federal guidelines). Knowledge of the clinical development process sufficient to manage multiple projects and timelines. Strong attention to detail, prioritization, and deadline adherence. Initiative and independent work capacity. Excellent interpersonal, oral and written communication and leadership skills. Proficiency in standard Microsoft Office applications (Word, PowerPoint, Excel, Project, and other project management tools). SOCRA or ACRP certification. Completion of supervisory training within one year of employment may be required. Equal Opportunity Consistent with state and federal law, the University of Utah does not discriminate based on race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender identity, pregnancy, 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 requirement not to discriminate in education programs or activities extends to admission and employment. For inquiries about Title IX or related regulations, please refer to the Title IX Coordinator or relevant department. #J-18808-Ljbffr