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PS Study Coordinator

Employer
University of Utah
Location
Utah, United States
Salary
Salary Not specified
Date posted
May 23, 2024

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Job Details



PS Study Coordinator

Job Summary

This position is within the Division of Epidemiology's Program for Addiction Research, Clinical Care, Knowledge and Advocacy (PARCKA). This position will coordinate the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. PARCKA's studies are conducted at various clinics in the Salt Lake City area. Job duties will require interaction with study participants, investigators, clinic and research staff, and study monitors. The incumbent will work closely with the project team to achieve study integrity and objectives through the successful implementation and completion of protocols and procedures.
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
Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Essential Functions

  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.

Comments

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.© 2021 The University of Utah • 250 East 200 South, Suite 125 Salt Lake City, Utah 84111 • 801.581.2169 The University of Utah |Disclaimer | Privacy | Webmaster


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


Special Instructions


Requisition Number: PRN38635B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 00952 - Division of Epidemiology
Location: Campus
Pay Rate Range: 31600 to 58400
Close Date: 5/30/2024
Open Until Filled: No

To apply, visit https://utah.peopleadmin.com/postings/165141


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