PS Study Coordinator

University of Utah; Salt Lake City (UT); On-site; USD 45,000 - 65,000; Full time

Job summary

University of Utah is seeking a Clinical Research Assistant to coordinate technical and administrative details in clinical or research studies, assisting the Principal Investigator in achieving study integrity and objectives through protocol implementation.

Responsibilities include protocol assessment, informed consent, subject safety, meeting participation, data collection, AE reporting, budget support, and compliance with FDA guidelines.

Qualifications

• Bachelor’s degree in a related field or equivalency; one year of education can substitute for two years of related work experience.
• IRB CITI Course in the Protection of Human Research Subjects certificate obtained within six months of hire.
• IATA DGR training may be required within six months.
• Vaccination requirements must be fulfilled or exemptions approved prior to first day of work.

Responsibilities

• Assess protocol for clarity and subject safety; review criteria with Principal Investigator and sponsor.
• Attend Investigator and staff meetings; advise team on assignments and timelines.
• Explain and obtain informed consent, medical history and demographics; document in source file and maintain with historical data, status reports, progress notes, and subject log to help ensure subject safety.
• Determine length of visits and coordinate facility and equipment availability.
• Report and track adverse events (AE); report serious AEs to IRB and sponsor.
• Document protocol deviations, reconcile test article accountability at study close out and prepare summary report for sponsor.
• Complete, audit, correct CRFs, and relay CRFs to sponsor.
• Assist with negotiating contract budget and payment terms.
• Maintain documents as required by FDA guidelines.
• May maintain contact with IRB and prepare and submit IRB documents.
• May ensure proper collection, processing and shipment of specimens.
• May perform functions required of the Clinical Research Assistant as necessary.

Skills

Communication skills

Education

Bachelor’s degree or equivalency

Job description

Job Summary

Coordinates technical and administrative details involved in a clinical or research study. Assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures.

Responsibilities

• Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
• Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.
• Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
• Determines length of visits and coordinates related facility and equipment availability.
• Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
• Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
• Completes, audits, corrects CRFs, relays CRFs to sponsor.
• Assists with negotiating contract budget and payment terms.
• Maintains documents as required by FDA guidelines.
• May maintain contact with IRB and prepare and submit IRB documents.
• May ensure proper collection, processing and shipment of specimens.
• May perform functions required of the Clinical Research Assistant as necessary.

Qualifications

• Bachelor’s degree in a related field, or equivalency (one year of education can be substituted for two years of related work experience) required. IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire, and demonstrated human relations and effective communication skills are also required.
• Some departments may require IATA DGR training within six months.
• 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.

Equal Employment Opportunity Statement

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.