Clinical Research Coordinators (Non-R.N.)
University of Utah, Salt Lake City, UT, United States
Clinical Research Coordinators (Non-R.N.) are responsible for managing day‑to‑day clinical trial activities in compliance with Good Clinical Practices (GCPs), study protocols, and applicable regulations. They coordinate research procedures, study visits, recruitment and enrollment, data collection, and adverse event reporting while working directly with participants and serving as the liaison between study teams, external partners, and regulatory agencies.
Responsibilities
Coordinate day‑to‑day clinical trial activities, including site qualification, initiation, monitoring visits, and close‑out activities.
Maintain source documents, report adverse events, and manage protocol deviations.
Recruit, screen, enroll, and obtain informed consent from study participants; manage study visits and follow‑up care.
Collect and maintain patient and laboratory data; develop and maintain study databases and investigational logs.
Prepare regulatory and investigative documentation, including IRB submissions, FDA filings, and related correspondence.
Develop and monitor study budgets, negotiate payment schedules with sponsors, and bill for allied services.
Lead compliance to protocol and quality control, preparing reports for stakeholders and regulatory agencies.
Mentor and train junior research staff and coordinate with referring physicians to sustain a strong referral base.
Represent the research program at meetings and consortiums, and contribute to educational materials for the community.
Assist the Principal Investigator in protocol development and study oversight.
Qualifications
Bachelor’s degree in a health sciences or related field (or equivalent), with at least two years of related research experience.
Strong organizational skills, attention to detail, and professional maturity.
Excellent communication abilities and experience working with multidisciplinary teams.
Knowledge of GCP, FDA, HIPAA, and IRB regulations; understanding of research procedures.
Completion of IRB CITI Course and/or IATA DGR training within specified timeframe.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined. This position may require the successful completion of a criminal background check and/or drug screen.
Veterans’ preference is extended to qualified applicants, upon request. Reasonable accommodations in the application process will be provided to individuals with disabilities.
Equal Opportunity Employment
The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education. Consistent with state and federal law, the University does not discriminate based on 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 accepts and encourages applications from Veteran and non‑Veteran candidates, and offers reasonable accommodations in the application process for individuals with disabilities. For more information about equal‑opportunity policies and for reporting discrimination, refer to the University’s non‑discrimination and reporting resources:
University of Utah Non‑Discrimination page , https://oeo.utah.edu, https://publicsafety.utah.edu/safetyreport/. The University’s policies are in accordance with Title IX and the Civil Rights Act.
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Responsibilities
Coordinate day‑to‑day clinical trial activities, including site qualification, initiation, monitoring visits, and close‑out activities.
Maintain source documents, report adverse events, and manage protocol deviations.
Recruit, screen, enroll, and obtain informed consent from study participants; manage study visits and follow‑up care.
Collect and maintain patient and laboratory data; develop and maintain study databases and investigational logs.
Prepare regulatory and investigative documentation, including IRB submissions, FDA filings, and related correspondence.
Develop and monitor study budgets, negotiate payment schedules with sponsors, and bill for allied services.
Lead compliance to protocol and quality control, preparing reports for stakeholders and regulatory agencies.
Mentor and train junior research staff and coordinate with referring physicians to sustain a strong referral base.
Represent the research program at meetings and consortiums, and contribute to educational materials for the community.
Assist the Principal Investigator in protocol development and study oversight.
Qualifications
Bachelor’s degree in a health sciences or related field (or equivalent), with at least two years of related research experience.
Strong organizational skills, attention to detail, and professional maturity.
Excellent communication abilities and experience working with multidisciplinary teams.
Knowledge of GCP, FDA, HIPAA, and IRB regulations; understanding of research procedures.
Completion of IRB CITI Course and/or IATA DGR training within specified timeframe.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined. This position may require the successful completion of a criminal background check and/or drug screen.
Veterans’ preference is extended to qualified applicants, upon request. Reasonable accommodations in the application process will be provided to individuals with disabilities.
Equal Opportunity Employment
The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education. Consistent with state and federal law, the University does not discriminate based on 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 accepts and encourages applications from Veteran and non‑Veteran candidates, and offers reasonable accommodations in the application process for individuals with disabilities. For more information about equal‑opportunity policies and for reporting discrimination, refer to the University’s non‑discrimination and reporting resources:
University of Utah Non‑Discrimination page , https://oeo.utah.edu, https://publicsafety.utah.edu/safetyreport/. The University’s policies are in accordance with Title IX and the Civil Rights Act.
#J-18808-Ljbffr