PS Study Coordinator

PS Study Coordinator

Job Summary

Study Coordinator job for Orthopaedic Clinical
Research. This position includes consenting patients, assisting with IRB application and other regulatory
functions for Orthopaedic surgery. 

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.Work Environment and Level of Frequency that may be requiredNearly
Continuously: Office environment.Physical Requirements and Level of Frequency that may be requiredNearly Continuously:
Sitting, hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking.Seldom: Bending, reaching overhead.

Minimum Qualifications
Bachelors 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:
PRN35326B
Full Time or Part Time? Full Time
Work Schedule Summary: M-F40 hours/week
Department: 00269 –
Orthopedic Surgery Operations
Location: Campus
Pay Rate Range: $50,000
Close Date:
Open Until
Filled: No

To apply, visit https://utah.peopleadmin.com/postings/150190

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