PS Clinical Site Monitor

Job Summary
Conduct monitoring of investigatorinitiated oncology clinical trials to ensure compliance to the protocol regulations guidance and standard operating procedures. Recommend corrections to monitoring findings and enhancements to study protocols and to operating policies and procedures. Report study progress toxicity summary and compliance issues to the HCI Data and Safety Monitoring Committee DSMC . Coordinate and oversee participation of outside sites on Huntsman Cancer Institute multisite clinical trials. 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. Partnerships with individuals communities and many other entities are crucial to our work. Huntsman Cancer Institute values cancerrelated health equity and inclusion as integral to our guiding principle to serve our patients and their communities and our commitment to foster a culture of belonging for all within our organization. In your cover letter or during your interview process we invite you to share how your personal and 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. Learn more here

Responsibilities
Essential Functions Oversee coordinate and conduct quality assurance reviews including monitor and audit visits on cancer related clinical trials to ensure compliance with study protocol University state and federal guidelines. Compile comprehensive reports for Principal Investigators DSMC and other committees as assigned. Administer and Support the Data and Safety Monitoring Committee. Assist in protocol development and maintenance. Develop monitor and update study specific case report forms and progress of the electronic data capture for each study. Analyze and document compliance processes. Recommends enhancements to operating policies and procedures for compliance review. Develop departmental SOPs. Develop coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues. Maintain current knowledge regarding federal and state guidance including Good Clinical Practice GCP . Problem Solving Incumbent is responsible for assisting the University in preparation for regulatory audits by developing monitoring and updating quality controls and recommending actions to maintain compliance. This position is the primary contact and expert regarding regulatory agency standards governing clinical trials. Representative challenges of this position include determining the validity of collected data assessing process shortfalls and developing effective safeguards to reduce risk. The incumbent must possess the ability to foster collaborative working relationships with a wide range of constituencies. Disclaimer This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It 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.

Minimum Qualifications
Bachelors degree in a health science or related field or equivalency (one year of education can be substituted for two years of related work experience); and four years of clinical research experience that includes regulatory compliance monitoring/auditing IRB application submission and experience in human subjects research. Must have a working knowledge of FDA ICH and other regulatory compliance; an understanding of medical terminology and technical writing experience. Excellent interpersonal communication (including oral and written) and leadership skills also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs. This position is patientsensitive and must fulfill all associated requirements. We protect our patients coworkers and community by requiring all patientsensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. Preferences include credentialing as a Certified Clinical Research Associate CCRA Certified Clinical Research Coordinator CCRC and/or Certified Clinical Research Professional CCRP . Prior experience as an industry CRA or Monitor is also preferred. Hiring department may require certification by an appropriate certifying body within two years of hire. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.