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.

About the Role

This 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.

Responsibilities

• 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
• Led 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
• Develops and coordinates 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
• Aids 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
• Coordinates with Regulatory team when needed to address regulatory-related matters
• Problem Solving

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

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