University of Utah Job Description
Performs on-site and remote auditing and monitoring activities and is responsible for regulatory oversight of clinical trials. Oversees, coordinates, and conducts auditing of clinical research projects. Ensures compliance by independently providing oversight on all aspects of the study. Oversees conduct of and reporting of data from all assigned clinical investigations.
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.
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.
This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
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.
1. Oversee, coordinate and conduct audits of clinical investigations to ensure compliance with University, Food and Drug Administration (FDA), Office of Human Research Protection (OHRP), Good Clinical Practice (GCP), state and federal guidelines. Responsible for performing on-site and/or remote monitoring activities independently.
2. Analyze and document auditing processes for all activities in the conduct of the clinical investigation, and recommend improvements to operating policies and procedures for compliance review. Monitor and follow up on required documentation related to audit processes.
3. Analyze and evaluate data gathered during research. Identify data discrepancies and missing data in source records or CRF’s.
4. Recognize protocol deviations and other study related issues and work to resolve and/or make appropriate recommendations for correction and full resolution.
5. Develop a monitoring plan for each new or existing project that describes the monitoring methods, responsibilities, and requirements utilized for the trial.
6. Team with faculty and staff to assist principal investigators, sites, divisions and departments in implementing compliance practices and procedures; monitors and coordinates those activities with the departments; and provides support to regulatory coordinators in terms of IRB submissions and compliance inquiries.
7. Develop, coordinate and participate in current educational and training programs offered to PI’s and study staff to enhance compliance and awareness of compliance issues.
8. Attend staff meetings and research professional’s grand rounds. Participate in training courses to better understand regulatory requirements, ICH guidelines and Good Clinical Practice as it relates to the overall conduct of clinical investigations and compliance to the monitoring plan.
This position is expected to recognize protocol deviations and other study related issues including those such as missing data, inconsistent data, and potential protocol deviations that may be indicative of significant errors in data collection and reporting at a site.
The incumbent decides how to best accomplish the daily requirements of various monitoring/auditing 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.
Monitoring reports will be compiled in collaboration with appropriate management and staff and presented in final form subsequently to the Principal Investigator to provide guidance regarding any clinical study findings in order to return the study to full regulatory compliance.
The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient's status and provide care as described in the department's policies and procedures manual.
250 East 200 South, Suite 125,
Salt Lake City, Utah 84111
Phone: 801.581.2169 Email: AskHR@utah.edu
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