Description:
The Clinical Trials Office at the University of Utah School of Medicine has an immediate opening for a Study Coordinator. The Study Coordinator coordinates technical and administrative details involved in clinical research studies, including Phase I – IV Clinical Trials, and assists Principal Investigators in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures.
The University of Utah offers an exceptional benefits package, a wellness program, and competitive salary commensurate with experience. Mutual respect and appreciation are highly valued within the University.
University of Utah Job ID# PRN13688B, Clinical Trials Office
COMPENSATION: $31,600 to $51,699 DOE. Strong benefit package including tuition reduction program, retirement and health plan options.
WORK SCHEDULE: Full-time, 40 hours/week, Monday–Friday, 9:00 a.m. to 5:30 p.m.; some weekends and after hours may be required.
RESPONSIBILITIES:
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. Maintains documents as required by FDA guidelines.
9. Maintains contact with IRB and prepares and submits IRB documents.
10. Ensures proper collection, processing and shipment of specimens.
11. Ensures uTRAC and any other University or departmental required tracking database is maintained.
12. Performs additional clinical research functions and assists research team members as required.
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.
PREFERENCES: Two years of professional clinical research experience strongly preferred. Applicants will be screened according to preferences.
Application Instructions:
PLEASE APPLY ONLINE THROUGH THE UNIVERSITY OF UTAH SYSTEM TO BE CONSIDERED FOR THIS JOB:
http://utah.peopleadmin.com/postings/61984
EQUAL EMPLOYMENT OPPORTUNITY
The University of Utah is an Affirmative Action/Equal Opportunity employer. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. Please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/TDD), for further information or to request an accommodation. The University of Utah is committed to diversity in its workforce. Women and minorities are encouraged to apply.