Job Description

University of Utah 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.

Qualifications

Bachelor's degree in a related field, or equivalency 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.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

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.