PS Clinical Research Coordinator

Job Summary PS Clinical Research Coordinator The Quality Assurance (QA) Specialist provides centralized support of the Hematology/BMT clinical research administrative programs by monitoring and improving the quality and compliance of administrative clinical research operations. This role is critical in ensuring that study documentation, regulatory processes, and trial management practices align with institutional, sponsor, and federal requirements. In collaboration with investigators, clinical research study teams, and clinical teams, the QA Specialist ensures regulatory compliance, operational efficiency, and consistently high standards of documentation and data integrity across the hematologic clinical trials portfolio. Responsibilities Administrative Quality Oversight – Conduct routine internal audits and targeted reviews of clinical trial documentation including regulatory binders, subject binders, source documentation, delegation and training logs, and trial master files for completeness and compliance. Monitor timeliness and quality of contemporaneous documentation, especially around adverse events, deviations, eligibility, and protocol‑required procedures in adherence to SOPs, Good Clinical Practice (GCP), and applicable regulations (FDA, ICH, NIH, etc.). Assist in external audit/inspection preparation, response coordination, and follow‑up documentation. Process Improvement & Compliance – Assist with development and implementation of QA tools and checklists specific to hematologic trials and administrative workflows; identify trends and gaps, provide recommendations, and help lead remediation efforts and implement corrective action and preventative actions (CAPAs). Support readiness for audits, sponsor monitoring visits, and regulatory inspections. Training & Education – Educate and coach study staff (coordinators, assistants, regulatory specialists) on documentation best practices and protocol adherence; assist with amending and creating SOPs, job aids, and reference materials aligned with GCP and sponsor expectations. Quality Metrics & Reporting – Track and analyze QA findings, providing data‑driven insights to leadership on performance, risk areas, and compliance metrics; assist in developing performance dashboards and corrective action plans where applicable. Minimum Qualifications Bachelor's degree in a health sciences or related field or equivalency with two years of professional research experience. Completion of University RATS Clinical Certification within one year of hire. Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; understanding of research procedures; ability to function independently. Experience with QA/QC methods in research or healthcare operations preferred. Patient‑sensitive position; must meet immunization requirements per CDC standards and hospital policy. Demonstrated potential to perform essential functions of the job as outlined in the position description. Preferences Current SOCRA or ACRP certification, or to be obtained within 6 months of employment. 3+ years of clinical research operations experience, preferably in hematology or oncology trials. Prior QA/QC experience within academic or NCI‑designated cancer centers. Experience with CTMS platforms (e.g., OnCore) and eReg systems. Strong communication skills and commitment to education and mentorship. Legal and Equal Opportunity Statements The University of Utah is an affirmative action/equal opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender identity, gender expression, pregnancy, genetic information, or protected veteran’s status. Veterans’ preference is extended to qualified applicants. Reasonable accommodations will be provided to individuals with disabilities. For further information, contact the Office of Equal Opportunity and Affiliation. #J-18808-Ljbffr