Job Summary
Clinical Research Associates (CRA)
The Clinical and Translational Sciences Institute (CTSI) is seeking a highly motivated individual to join our team providing QA and compliance support for the Clinical Research Support Office (CRSO) ensuring continuity and increasing efficiencies between the different Departments and study teams.
The Clinical Research Associate, II will perform on-site and remote monitoring of moderate-high risk clinical studies. Oversees, coordinates and conducts monitoring reviews of multiple clinical research projects within the University of Utah. Position provides independent regulatory oversight of all aspects of study conduct at the site, or institutional level. Ensures compliance with University policies, State and Federal regulations. Expertise in human subject research and experience working with the FDA and ICH GCP regulations are required. Must have the ability to Independently perform all on-site or remote monitoring activities.
Click here to learn more about the CTSI
Learn more about the fantastic benefits provided to University of Utah Employees including generous retirement contribution, comprehensive medical coverage, tuition reduction, and more.
Responsibilities
Clinical Research Associate (CRA), IIRequires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.
Monitor clinical studies in accordance with FDA regulations, ICH guidelines, IRB policies, protocol specifications and monitoring plan. Reviews investigational product accountability records for accuracy. Analyzes and documents monitoring review findings and creates monitoring reports. Reviews site monitoring reports and discusses findings with clinical study teams and Investigators. Provides guidance for appropriately returning the clinical study to full regulatory compliance. Works in collaboration with the Office of Research Integrity and Compliance, Huntsman Cancer Institute and Internal Medicine along with other Departments campus wide to develop campus-wide processes and procedures. Works closely with the CRSO QA team to develop, monitor, and update quality control systems for tracking compliance activities. Identifies issues, trends, and risk areas. Recommends improvements to operating policies and procedures.Participates in educational and training programs to promote compliance and enhance awareness of compliance issues. Assist in conducting training on an individual, department, institutional, and multi-institutional level. Teams up with faculty and staff to assist investigators, sites, divisions and departments in implementing compliance practices and monitors and coordinates those activities with the departments.Problem Solving:The incumbent decides how to best accomplish the daily requirements of various monitoring 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. Functions under minimal supervision, following FDA, GCP, IRB, NIH, and any other relevant regulatory agency policies, regulations and guidelines. Must be able to independently make decisions regarding study procedures and protocol issues as well as recognize and resolve protocol deviations.DisclaimerThis 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
EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).Department may hire employee at one of the following job levels:
Clinical Research Associate (CRA), II: Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.
Preferences
- Experience with human subject research, and working knowledge of ICH, GCP, and FDA regulations.