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
- 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. - 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.
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
Applicants with Spanish language fluency are strongly preferred.
Special
Instructions
Requisition Number: PRN35547B
Full Time or Part Time? Full Time
Work Schedule Summary:
M-F 8-5
Department: 01720 – PHS – HEALTH SYS INNO & RSRCH
Location: Campus
Pay Rate Range: 42000 to
58000
Close Date:
Open Until Filled: Yes
To apply, visit https://utah.peopleadmin.com/postings/150326
jeid-719f08d6f88cf54ead451d734276f36f
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