"Clinical Site Monitor"

Job Summary

Conduct monitoring of investigator-initiated 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 the participation of outside sites on Huntsman Cancer Institute multi-site 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. 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

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.

Essential Functions

1. 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.
2. Compile comprehensive reports for Principal Investigators, DSMC and other committees as assigned.
3. Administer and Support the Data and Safety Monitoring Committee.
4. Assist in protocol development and maintenance.
5. Develop, monitor, and update study specific case report forms and progress of the electronic data capture for each study.
6. Analyze and document compliance processes. Recommends enhancements to operating policies and procedures for compliance review.
7. Develop departmental SOPs. Develop, coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues.
8. 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.

Minimum Qualifications

Bachelor's 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 patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive 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.

Preferences

• Certified Clinical Research Professional (CCRP, CCRC or CCRA)
• Prior experience or knowledge of oncology, and oncology related research
• Prior experience with Institutional Review Board (IRB) procedures
• Strong written and oral communication skills
• An understanding of University operations, policies and technology is preferred. Training or teaching experience is also preferred.