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PS Study Coordinator

University of Utah

Salt Lake City (UT)

On-site

USD 45,000 - 75,000

Full time

20 days ago

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Job summary

An established industry player is seeking a detail-oriented individual to coordinate technical and administrative aspects of clinical or research studies. This role involves assisting the Principal Investigator in ensuring study integrity through effective communication and documentation. The ideal candidate will have a Bachelor's degree in a related field and strong interpersonal skills. Join a dynamic team dedicated to improving healthcare access and quality for diverse populations. If you are passionate about research and patient care, this opportunity is perfect for you!

Benefits

Retirement plan
Health insurance
Flexible work hours
Professional development opportunities

Qualifications

  • Bachelor’s degree or equivalent experience required.
  • IRB CITI Course certification within six months of hire.

Responsibilities

  • Coordinates technical and administrative details of clinical studies.
  • Documents informed consent and maintains subject safety.
  • Tracks adverse events and prepares reports for sponsors.

Skills

Effective communication skills
Human relations skills
Knowledge of patient care
Ability to assess data regarding patient status

Education

Bachelor’s degree in a related field
IRB CITI Course certification

Job description

Priority Review Date (Note - Posting may close at any time)

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.
  • 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.
  • 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.

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.

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.

This position is patient-sensitive and must fulfill all associated requirements. 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.

Some departments may require IATA DGR training within six months.

Preferences

Preferred Skills:

  • The ability to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on their assigned unit.
  • The ability to demonstrate knowledge of the principles of life span growth and development.
  • The ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.

Special Instructions Summary

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 (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions.

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 patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.

All qualified individuals are strongly encouraged to apply. 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.

The University of Utah is an Affirmative Action/Equal Opportunity employer and 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.

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 Affirmative Action (OEO /AA).

Online reports may be submitted at oeo.utah.edu

Posting Specific Questions

Required fields are indicated with an asterisk (*).

  • * Do you have a related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)
    • Yes
    • No

Required Documents

  • Resume

Optional Documents

  • Cover Letter
  • List of References

University Human Resource Management
250 East 200 South, Suite 125 Salt Lake City, UT 84111
Contact us: (801) 581-2169 By Email: employment@utah.edu

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