PS Clinical Research Coord
University of Utah, Murray, UT, United States
Working Title Clinical Research Coordinator - Midvalley Dermatology
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 study team to achieve objectives, coordinating research procedures, study visits, and follow-up care.
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.
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 a 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.
Prepares regulatory documents, including consent forms for submission to research review committees.
Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
Tracks study approvals and expirations to ensure uninterrupted project approval.
Tracks sponsor and investigator initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB).
Submits study renewal applications and study progress reports to the IRB.
Coordinates 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.
Mentors and trains new research staff.
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. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
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.
Work Environment
Nearly continuously: Office environment.
Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids).
Physical Requirements
Nearly continuously: Hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking, standing, sitting.
EEO Statement
Consistent with state & 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 of Utah does not discriminate on the basis of sex in the education program or activity, and extends and implements, as consistent with Title IX, standards and a compliance program that protects against gender‑based discrimination, sex‑based discrimination, and sexual‑violence, with an eye toward fairness, justice, and equity. 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. The University of Utah remains open to all applicants and ensures equal opportunity.
#J-18808-Ljbffr
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 study team to achieve objectives, coordinating research procedures, study visits, and follow-up care.
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.
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 a 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.
Prepares regulatory documents, including consent forms for submission to research review committees.
Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
Tracks study approvals and expirations to ensure uninterrupted project approval.
Tracks sponsor and investigator initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB).
Submits study renewal applications and study progress reports to the IRB.
Coordinates 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.
Mentors and trains new research staff.
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. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
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.
Work Environment
Nearly continuously: Office environment.
Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids).
Physical Requirements
Nearly continuously: Hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking, standing, sitting.
EEO Statement
Consistent with state & 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 of Utah does not discriminate on the basis of sex in the education program or activity, and extends and implements, as consistent with Title IX, standards and a compliance program that protects against gender‑based discrimination, sex‑based discrimination, and sexual‑violence, with an eye toward fairness, justice, and equity. 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. The University of Utah remains open to all applicants and ensures equal opportunity.
#J-18808-Ljbffr