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 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 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 Institutes mission and this position.

Responsibilities
Essential Functions: Please include a cover letter with your application detailing your interest and qualifications for this position. 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 Leads day to day operations of the Research Compliance Office programs including monitoring audits and quality assurance reviews Provides oversight and direction for the Clinical Site Monitors Clinical Site Auditors and Data Management staff Supports the Data and Safety Monitoring Committee ( DSMC ) by ensuring the Research Compliance Office follows the NCI approved Data and Safety Monitoring Plan Reviews and ensures the accuracy of comprehensive reports provided to the DSMC Proactively identifies prioritizes and implements policies and procedural changes to enhance efficiencies of research activities at HCI Develops and implements 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 Keeps current on new local and federal regulations rules revisions and other industry standards that govern human subject research Conducts for-cause and spot audits of clinical trials Assists in internal and external audits of research activities Collaborates on investigations of matters of suspected non-compliance with appropriate key stakeholders to determine the appropriate corrective and preventative action plan Creates metrics to improve performance efficiency and quality of research activities at HCI Participates in projects as assigned to promote research compliance Coordinates with 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. This position 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 of all involved following 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. This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to the job. Work Environment and Level of Frequency that may be required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting hearing listening talking. Often: Repetitive hand motion (such as typing) walking. Seldom: Bending reaching overhead.

Minimum Qualifications
Bachelors 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 hiring departments area of specialization in order to analyze plan and draw conclusions for recommendations to superiors. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop subordinates and to ensure the smooth operation of department. Masters degree in a related area may be preferred. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.