Job Details

Manager, Clinical Research

Position Number: 7085376
Location: Salt Lake City, UT
Position Type: Medicine - Medical Researcher

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 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: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 SolvingThis 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 requiredNearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be requiredNearly 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 hiring department's 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. Master's 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.

Preferences

Three to Five (3-5) years 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: Food and Drug Administration (FDA) requirements, Office of Human Research Protection (OHRP), International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines
Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines
Strong attention to detail, establishing priorities, and adhering to deadlines.
Able to show initiative and work independently, take initiative and complete tasks to meet deadlines
Excellent interpersonal communication (including oral and written) and leadership skills also 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.

Special Instructions

Requisition Number: PRN44751B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 01345 - HCI Clinical Resrch Compliance
Location: Campus
Pay Rate Range: 60700 to 115300
Close Date: 7/15/2026
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/200261