PS Clinical Research Coord

Job Summary
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. Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide. In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute's mission and this position.

Responsibilities
Key Responsibilities Administrative Quality Oversight Conduct routine internal audits and targeted reviews of clinical trial documentation including regulatory binders, subject binders and 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 the development and implementation of QA tools and checklists specific to hematologic trials and administrative workflows. Identify trends and gaps in documentation and operations; provide recommendations, help to 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 , institutional policy, 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. Key Competencies High attention to detail with a proactive problem-solving mindset. Ability to collaborate across teams and influence process improvement. Strong communication skills and a commitment to education and mentorship.

Minimum Qualifications
Bachelors degree in a health sciences or related field or equivalency (one year of education can be substituted for two years of related work experience) with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required. Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred. Departments may require IRB CITI Course or IATA DGR training within a specified timeframe. Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification. This position is patient-sensitive and must fulfill all associated requirements. 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.

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