Clinical Research Associate (CRA), II

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 departments and study teams.

About the role

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. 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.

Responsibilities

• Monitor clinical studies in accordance with FDA regulations, ICH guidelines, IRB policies, protocol specifications, and monitoring plan.
• Review investigational product accountability records for accuracy.
• Analyze and document monitoring review findings and create monitoring reports.
• Review site monitoring reports and discuss findings with clinical study teams and Investigators.
• Provide guidance for appropriately returning the clinical study to full regulatory compliance.
• Work 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.
• Work closely with the CRSO QA team to develop, monitor, and update quality control systems for tracking compliance activities.
• Identify issues, trends, and risk areas. Recommend improvements to operating policies and procedures.
• Participate 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.
• Team up with faculty and staff to assist investigators, sites, divisions, and departments in implementing compliance practices and monitor and coordinate those activities with the departments.
• Decide how to best accomplish daily requirements of various monitoring objectives, prioritize workload, and establish systems needed to achieve specific goals.
• Coordinate efforts of multiple departments or disciplines to ensure effective follow-through and compliance.
• Function under minimal supervision, following FDA, GCP, IRB, NIH, and any other relevant regulatory agency policies, regulations, and guidelines.
• Independently make decisions regarding study procedures and protocol issues as well as recognize and resolve protocol deviations.

Requirements

• Bachelor’s degree (or equivalency) plus 4 years of directly related work experience, or a master’s degree (or equivalency) plus 2 years of directly related work experience.
• Experience with human subject research and working knowledge of ICH, GCP, and FDA regulations.
• Ability to write clear and concise reports and present information effectively in various communication settings.
• Strong interpersonal, leadership, and customer service skills.
• Excellent communication and writing skills.
• Availability to travel locally as needed to conduct monitoring of clinical research studies.
• Certification as a Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) preferred or ability to obtain after hire.

Benefits

• Generous retirement contribution.
• Comprehensive medical coverage.
• Tuition reduction.

Pay

$65,000-$70,000

Schedule

Full-time, Monday through Friday, 9:00 AM to 5:00 PM.