Clinical Research Coordinator - Midvalley Dermatology
University of Utah, Murray, UT, United States
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.
Responsibilities
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. Works 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.
Minimum Qualifications
Bachelor's 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 vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.
This position may require the successful completion of a criminal background check and/or drug screen.
Preferences
Clinical Research Certification or eligibility to obtain certification within 6 months of hire is preferred.
Completion of CITI and GCP trainings required upon hire.
Legal and Non‑Discrimination Statements
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.
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. 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 Title IX (OEO). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the: University of Utah Non‑Discrimination page.
Online reports may be submitted at https://oeo.utah.edu. https://publicsafety.utah.edu/safetyreport/. This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offences. 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.
As per University of Utah policy 5‑108: Transfer of Benefits Eligible Staff Members, a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period.
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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.
Responsibilities
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. Works 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.
Minimum Qualifications
Bachelor's 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 vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.
This position may require the successful completion of a criminal background check and/or drug screen.
Preferences
Clinical Research Certification or eligibility to obtain certification within 6 months of hire is preferred.
Completion of CITI and GCP trainings required upon hire.
Legal and Non‑Discrimination Statements
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.
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. 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 Title IX (OEO). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the: University of Utah Non‑Discrimination page.
Online reports may be submitted at https://oeo.utah.edu. https://publicsafety.utah.edu/safetyreport/. This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offences. 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.
As per University of Utah policy 5‑108: Transfer of Benefits Eligible Staff Members, a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period.
#J-18808-Ljbffr