Clinical Research Associate (CRA), II

Clinical Research Associates (CRA) at the Clinical and Translational Sciences Institute (CTSI) provide QA and compliance support for the Clinical Research Support Office (CRSO), ensuring continuity and increasing efficiencies between departments and study teams. The Clinical Research Associate, II performs on-site and remote monitoring of moderate-high risk clinical studies, oversees and conducts monitoring reviews of multiple clinical research projects, and 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.

About the role

The Clinical Research Associate, II will independently perform all on-site or remote monitoring activities, ensuring compliance with FDA regulations, ICH guidelines, IRB policies, protocol specifications, and monitoring plans.

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.
• Collaborate with the Office of Research Integrity and Compliance, Huntsman Cancer Institute, Internal Medicine, and other departments 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 those activities.
• Coordinate efforts of multiple departments or disciplines to ensure effective follow-through and compliance.
• Independently make decisions regarding study procedures, protocol issues, 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.

Preferences

• 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 per year.

Schedule

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