Clinical Research Coordinators (Non-R.N.)
University of Utah Health Research, Salt Lake City, UT, United States
Job Summary
Clinical Research Coordinators (Non‑R.N.) coordinate day‑to‑day clinical trial activities in accordance with Good Clinical Practices (GCPs), study protocols, and applicable regulations. They implement processes, manage study metrics, conduct study initiation and monitoring visits, maintain source documents, and recruit, screen, enroll, and obtain consent from study participants. The role works under the direction of the Primary Investigator (PI) and is patient‑sensitive, requiring complete immunization as per CDC standards.
Responsibilities
Oversee compliance to protocol; manage quality control, completion and submission of study‑related documentation; prepare reports for organizations and agencies.
Develop study budgets; monitor budget expenses and billing for allied services; negotiate payment schedules with sponsors and fees for internal services.
Monitor enrollment goals and initiate strategies to promote enrollment and participant compliance. Coordinate and perform responsibilities related to research participants, including determining subject population availability, developing informed consents and screening materials, recruiting and scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study‑related parties.
Recognize, track, and report adverse events and protocol deviations.
Prepare for and coordinate site visits made by sponsors or federal agencies during the course and at the close of the study.
Represent the research program at meetings, national and international research consortia.
Prepare, submit and maintain IRB, FDA, NCI, NIH, NSF and other regulatory documents and research correspondence.
Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues.
Supervise, mentor and train new or junior research staff.
Coordinate with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
Develop and maintain patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
Assist the Principal Investigator in the development of study protocols.
Qualifications
Bachelor’s degree in a health sciences or related field with two years of professional research experience, or equivalent.
Exceptional organizational skills, attention to detail, and effective communication skills.
Experience with scientific writing, data analysis, and working with multidisciplinary teams.
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; understanding of research procedures and the ability to function independently.
Completion of IRB CITI Course and/or IATA DGR training within a specified timeframe.
Minimum Qualifications & Preferences
1 year of higher education can be substituted for 1 year of directly related work experience.
Preferences : Spanish language fluency and/or master’s degree.
Job Levels & Pay Ranges
Level I (Entry‑Level)
– Bachelor’s (or equivalency) with up to 2 years of directly related experience or a master’s degree. Grade: P11. Expected Pay: $24,722 – $56,715.
Level II (Developing‑Level)
– Bachelor’s with 4 years or a master’s with 2 years of directly related experience. Grade: P13. Expected Pay: $29,913 – $68,625.
Level III (Career‑Level)
– Bachelor’s with 6 years or a master’s with 4 years of directly related experience. Grade: P15. Expected Pay: $36,196 – $83,036.
EEO Statement
The University of Utah is an equal opportunity employer. We do not discriminate on the basis of race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender identity, pregnancy, pregnancy‑related conditions, genetic information, or veteran’s status.
#J-18808-Ljbffr
Clinical Research Coordinators (Non‑R.N.) coordinate day‑to‑day clinical trial activities in accordance with Good Clinical Practices (GCPs), study protocols, and applicable regulations. They implement processes, manage study metrics, conduct study initiation and monitoring visits, maintain source documents, and recruit, screen, enroll, and obtain consent from study participants. The role works under the direction of the Primary Investigator (PI) and is patient‑sensitive, requiring complete immunization as per CDC standards.
Responsibilities
Oversee compliance to protocol; manage quality control, completion and submission of study‑related documentation; prepare reports for organizations and agencies.
Develop study budgets; monitor budget expenses and billing for allied services; negotiate payment schedules with sponsors and fees for internal services.
Monitor enrollment goals and initiate strategies to promote enrollment and participant compliance. Coordinate and perform responsibilities related to research participants, including determining subject population availability, developing informed consents and screening materials, recruiting and scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study‑related parties.
Recognize, track, and report adverse events and protocol deviations.
Prepare for and coordinate site visits made by sponsors or federal agencies during the course and at the close of the study.
Represent the research program at meetings, national and international research consortia.
Prepare, submit and maintain IRB, FDA, NCI, NIH, NSF and other regulatory documents and research correspondence.
Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues.
Supervise, mentor and train new or junior research staff.
Coordinate with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
Develop and maintain patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
Assist the Principal Investigator in the development of study protocols.
Qualifications
Bachelor’s degree in a health sciences or related field with two years of professional research experience, or equivalent.
Exceptional organizational skills, attention to detail, and effective communication skills.
Experience with scientific writing, data analysis, and working with multidisciplinary teams.
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; understanding of research procedures and the ability to function independently.
Completion of IRB CITI Course and/or IATA DGR training within a specified timeframe.
Minimum Qualifications & Preferences
1 year of higher education can be substituted for 1 year of directly related work experience.
Preferences : Spanish language fluency and/or master’s degree.
Job Levels & Pay Ranges
Level I (Entry‑Level)
– Bachelor’s (or equivalency) with up to 2 years of directly related experience or a master’s degree. Grade: P11. Expected Pay: $24,722 – $56,715.
Level II (Developing‑Level)
– Bachelor’s with 4 years or a master’s with 2 years of directly related experience. Grade: P13. Expected Pay: $29,913 – $68,625.
Level III (Career‑Level)
– Bachelor’s with 6 years or a master’s with 4 years of directly related experience. Grade: P15. Expected Pay: $36,196 – $83,036.
EEO Statement
The University of Utah is an equal opportunity employer. We do not discriminate on the basis of race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender identity, pregnancy, pregnancy‑related conditions, genetic information, or veteran’s status.
#J-18808-Ljbffr