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Details

**Open Date** 07/02/2025

**Requisition Number** PRN42373B

**Job Title** PS Clinical Research Coord

**Working Title** Clinical Research Coordinator

**Job Grade** E

**FLSA Code** Administrative

**Patient Sensitive Job Code?** Yes

**Standard Hours per Week** 40

**Full Time or Part Time?** Full Time

**Shift** Day

Work Schedule Summary

**VP Area** President

**Department** 01167 - HCI Clinical Trials Operations

**Location** Campus

**City** Salt Lake City, UT

**Type of Recruitment** External Posting

**Pay Rate Range** 39300 to 54807.38

**Close Date** 09/30/2025

Priority Review Date (Note - Posting may close at any time)

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.

Minimum Qualifications:

+ Bachelor’s degree in life sciences, public health, healthcare administration, or related field.

+ Current SOCRA or ACRP certification – or to be obtained within 6 months of employment.

+ 3+ years of experience in clinical research operations, preferably in hematology or oncology trials.

+ Demonstrated knowledge of ICH - GCP , FDA regulations, and clinical trial lifecycle.

+ Strong documentation, organizational, and analytical skills.

Preferred Qualifications:

+ Prior QA/QC experience within academic or NCI -designated cancer centers.

+ Experience with QA/QC methods in research or healthcare operations.

+ Familiarity with CTMS platforms (e.g., OnCore) and eReg systems.

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.

_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.

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.

Preferences

**Type** Benefited Staff

Special Instructions Summary

Additional Information

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.

This position may require the successful completion of a criminal background check and/or drug screen.

The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.

All qualified individuals are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.

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, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.

To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action ( OEO /AA). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/

Online reports may be submitted at oeo.utah.edu

https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.