PS Study Coordinator

Utah; Salt Lake City (UT); On-site; USD 45,000 - 70,000; Full time

Job summary

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

Responsibilities include evaluating protocols for safety and clarity, attending meetings, obtaining consent and demographics, coordinating visits, documenting data, and reporting adverse events while ensuring regulatory compliance with IRB and FDA guidelines.

Qualifications

• Bachelor’s degree in a related field; equivalency allowed; IRB CITI course within 6 months.
• Demonstrated human relations and effective communication skills.
• IATA DGR training within six months may be required in some departments.

Responsibilities

• Assesses protocol for clarity and subject safety; reviews inclusion/exclusion criteria with PI and sponsor.
• Attends and participates in Investigator and staff meetings; advises team on assignments and timelines.
• Obtains informed consent, medical history and demographics; documents in source file and maintains with data.
• 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 protocol deviations and reconciles test article accountability at study close; prepares sponsor summary.
• Completes, audits, corrects CRFs and relays to sponsor.
• Assists with negotiating contract budgets and payment terms.
• Maintains documents as required by FDA guidelines.
• May contact IRB and submit IRB documents.
• May ensure proper collection, processing and shipment of specimens.
• Performs responsibilities as Clinical Research Assistant as needed.

Skills

Communication skills

Human relations

Team coordination

Patient safety awareness

Education

Bachelor's degree in a related field

IRB CITI Certification

IATA DGR training (within six months)

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

1. Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
2. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.
3. 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.
4. Determines length of visits and coordinates related facility and equipment availability.
5. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
6. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
7. Completes, audits, corrects CRFs, relays CRFs to sponsor.
8. Assists with negotiating contract budget and payment terms.
9. Maintains documents as required by FDA guidelines.
10. May maintain contact with IRB and prepare and submit IRB documents.
11. May ensure proper collection, processing and shipment of specimens.
12. May perform functions required of the Clinical Research Assistant as necessary.

Problem Solving

Incumbents are responsible for coordinating the daily operations of their assigned research team, coordinating the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives.

Work Environment and Level of Frequency that may be required

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.

The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.

Minimum 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.

Preferences

Preferential hiring for Veterans and applicants applying for reasonable accommodations for disability, consistent with University policy and Utah state law.

Additional Information

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at [phone] for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at [phone] or [phone] or University Human Resource Management at [phone] if you have questions regarding the post-retirement rules.

This position may require the successful completion of a criminal background check and/or drug screen.

The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education.

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. For additional safety services, contact 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.