PS Study Coordinator
About The Position
The Clinical Trails Office at University of Utah School of Medicine has an immediate opening for a Study Coordinator. The Study Coordinator 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. The University of Utah offers a comprehensive benefits package including: Excellent health care coverage at affordable rates 14.2% retirement contributions that vest immediately Generous paid leave time 11 paid Holidays per year 50% tuition reduction for employee, spouse, and dependent children Flex spending accounts Free transit on most UTA services Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel Professional development opportunities Additional benefits information is available at www.hr.utah.edu/benefits
Requirements
- 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.
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.
- Maintain contact with IRB and prepare and submit IRB documents.
- Ensure proper collection, processing and shipment of specimens.
- Perform functions required of the Clinical Research Assistant as necessary.
Benefits
- Excellent health care coverage at affordable rates
- 14.2% retirement contributions that vest immediately
- Generous paid leave time
- 11 paid Holidays per year
- 50% tuition reduction for employee, spouse, and dependent children
- Flex spending accounts
- Free transit on most UTA services
- Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
- Professional development opportunities
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What This Job Offers
Job Type
Full-time
Number of Employees
5,001-10,000 employees
