Manager, Clinical Research

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 will ensure proper oversight of all Investigator Initiated Trials (IIT) as well as non‑IIT studies conducted at HCI. The position reports to the Director of Research Compliance Office and collaborates with partner departments such as 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. Responsibilities Collaborate with key research leadership, employees, physicians, members of the Institutional Review Board (IRB) and research study sponsors to identify, investigate, and resolve research‑related compliance issues by serving as an internal expert and advisor in clinical research compliance matters. Lead day‑to‑day operations of the Research Compliance Office programs, including monitoring, audits, and quality assurance reviews. Provide oversight and direction for the 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 policies and procedural changes to enhance efficiencies of research activities at HCI. Develop and implement methods, strategies, and standard operating procedures to ensure all compliance needs are met. Develop, coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues. Keep current on new local and federal regulations, rules, revisions, and other industry standards that govern 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 matters of suspected non‑compliance with appropriate key stakeholders to determine the appropriate corrective and preventative action plan. Create metrics to improve performance, efficiency and quality of research activities at HCI. Participate in projects as assigned to promote research compliance. Coordinate with Regulatory team when needed to address regulatory‑related matters. Problem Solving This position utilizes federal, institutional guidelines and requirements to inform and complete the submission of regulatory documents. It also negotiates with University research committees and sponsors to ensure full compliance and communication. The incumbent decides how to best accomplish the daily requirements of various regulatory objectives, prioritizes workload, and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance with FDA, Good Clinical Practice, IRB, NIH, and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team. Work Environment and Physical Requirements Work Environment: Nearly continuously – office environment. Physical Requirements: Nearly continuously – sitting, hearing, listening, talking. Often – repetitive hand motion (such as typing), walking. Seldom – bending, reaching overhead. Minimum Qualifications Bachelor's degree in a related area or equivalency (one year of education can be substituted for two years of related work experience). Four to six years of progressively more responsible management experience. Background knowledge of the hiring department's area of specialization. Demonstrated leadership skills in planning and directing employees and processes to effectively monitor and develop subordinates and ensure smooth operation of the department. Master’s degree in a related area may be preferred. Preferences Three to five (3‑5) years of working experience in a research compliance or a similar quality auditing environment with expertise, knowledge, and GCP experience in auditing clinical trials. 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, including but not limited to FDA requirements, OHRP, ICH Good Clinical Practice, and state and federal guidelines. Knowledge of the clinical development process sufficient to effectively direct and manage multiple projects and timelines. Strong attention to detail, establishing priorities, and adhering to deadlines. Ability to show initiative and work independently, take initiative and complete tasks to meet deadlines. Excellent interpersonal communication (including oral and written) and leadership skills required. Proficient in standard Microsoft Office applications including Word, PowerPoint, Excel, Project, and other project management tools. SOCRA or ACRP certification. Completion of provided supervisory training within one year of employment may be required. Job Details Requisition Number: PRN44751B Full Time or Part Time? Full Time Department: 01345 - HCI Clinical Research Compliance Location: Campus Pay Rate Range: 60,700 to 115,300 Close Date: 7/15/2026 Open Until Filled: Yes How to Apply Visit to apply. #J-18808-Ljbffr The Chronicle Of Higher Education, Inc.