Clinical Research Coordinator - Midvalley Dermatology
University of Utah Health Research, 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.
This position is patient-sensitive and requires full vaccination according to CDC standards or an approved exemption prior to first day of work.
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. 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 health sciences or related field (or equivalency), with two years of professional research experience and completion of University RATS Clinical Certification within one year of hire.
Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills.
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and ability to function independently.
Preferences
Clinical Research Certification or eligibility to obtain certification within 6 months of hire.
Completion of CITI and GCP trainings required upon hire.
Preferred nursing degree with two years related experience and nationally recognized research compliance certification.
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, genetic information, or protected veteran’s status. Reasonable accommodations will be provided to individuals with disabilities.
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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.
This position is patient-sensitive and requires full vaccination according to CDC standards or an approved exemption prior to first day of work.
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. 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 health sciences or related field (or equivalency), with two years of professional research experience and completion of University RATS Clinical Certification within one year of hire.
Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills.
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and ability to function independently.
Preferences
Clinical Research Certification or eligibility to obtain certification within 6 months of hire.
Completion of CITI and GCP trainings required upon hire.
Preferred nursing degree with two years related experience and nationally recognized research compliance certification.
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, genetic information, or protected veteran’s status. Reasonable accommodations will be provided to individuals with disabilities.
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