Clinical Research Coordinator - Midvalley Dermatology Job Murray area,Utah USA,Healthcare

Job Summary

Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Implement processes and organize efforts within the study team to achieve objectives, coordinating research procedures, study visits, and follow-up care.

This position is patient-sensitive and requires all patient-sensitive employees to be immunized according to CDC standards and hospital policy, with limited exemptions for documented medical contraindications or religious beliefs.

Responsibilities

Create and maintain tools and documentation to track study metrics, providing updates to management.

Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities.

Maintain source documents and report adverse events.

Recruit, screen, enroll, and obtain consent from study participants.

Collect and maintain patient and laboratory data.

Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies under the direction of the Primary Investigator (PI).

Attain and retain Clinical Research Coordinator Certification (CCRC).

Understand the process of preparing, submitting, and maintaining IRB, FDA, and/or other regulatory documents and research correspondence.

Prepare regulatory documents, including consent forms for submission to research review committees.
Communicate with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
Track study approvals and expirations to ensure uninterrupted project approval.
Track sponsor and investigator-initiated amendment notifications and submit amended protocols, summaries and consents to the Institutional Review Board (IRB).
Submit study renewal applications and study progress reports to the IRB.
Coordinate with study sponsor, investigator and IRB to complete study closure activities.

Complete time budget assessments and designate study charges vs. standard of care on clinical trials.

Maintain regulatory database.

Mentor and train new research staff.

Qualifications

Bachelor’s degree in a health sciences or related field or equivalent (one year of education can substitute for two years of related work experience) with two years of 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 are 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. A nursing degree is preferred, requiring two years of related experience and a nationally recognized research compliance certification.

EEO Statement

The University of Utah values candidates who have experience working in settings with students and possesses a strong commitment to improving access to higher education.

Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Reasonable accommodations in the application process will be provided to individuals with disabilities.

Consistent with state and federal law, the University of Utah 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.

Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, the Department of Education, Office for Civil Rights, or both.

To request a reasonable accommodation for a disability or if you have experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Title IX (OEO). More information, including the office address, electronic mail address, and telephone number can be located at the University of Utah Non-Discrimination page. Online reports may be submitted h.edu.

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