Study Coordinator (15233B)

Date: Posted 11-Sep-2017, Closing 10-Nov-2017 (MST)

Department: Other

Location: Salt Lake City, UT

Pay Rate: $31,600 to $51,699 DOE

Pay Type: Salary

Benefits: Strong benefit package including generous leave accrual, retirement and health plan options.

Employment Type: Full Time

The Department of Pediatrics at the University of Utah, School of Medicine has an immediate opening for a Study Coordinator to provide support to the research team and Principal Investigators in the Division of Pediatric Endocrinology. This position is responsible for coordinating the technical and administrative details involved in a clinical or research study; as well as assisting the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures. Responsibilities include: assessing eligibility criteria; interfacing with patients and their families; obtaining informed consent; collecting data; entering study data into various EDC systems as determined by specific projects; preparation of regulatory documentation. Cross training to provide coverage for other trials and services supported by the division may be required.

 

University of Utah Job ID# PRN15233B, Pediatric Endocrinology

 

COMPENSATION: $31,600 to $51,699 DOE. Strong benefit package including generous leave accrual, retirement and health plan options.

 

WORK SCHEDULE: Full-time, 40 hour/week, Weekdays and occasional weekends. Hours may vary to meet study participants scheduling needs.

 

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. Recognizes, tracks and reports adverse events (AE). Reports serious AEs to IRBand 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 FDAguidelines.
  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.
  13. Oversees compliance to study protocols, as defined by on-going and projected trials; manages quality control, completion and submission of study related documentation; prepares reports for research manager, Principal Investigators and sponsors, as requested. 
  14. Disseminates information about protocols to diabetes clinic staff where applicable.
  15. Assists with preparation and coordination of site visits made by CROs, sponsors and/or federal agencies during the course of and at the close of the study. 
  16. Assures proper laboratory samples are collected and results are reported to the proper entities.
  17. Attends all appropriate meetings as determined by the Principal Investigator and Pediatric Endocrinology Research Manager.
  18. Cross-trains to provide coverage for existing research staff.

 

QUALIFICATIONS: Bachelors 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.

 

Excellent interpersonal and communications skills, both oral and written. Proficiency in Microsoft Office and ability to learn new software programs. Exceptional ability to quickly prioritize tasks in a dynamic environment, strong organizational skills and attention to detail. Ability to function independently is preferred.

 

PLEASE APPLY ONLINE THROUGH THE UNIVERSITY OF UTAH SYSTEM TO BE CONSIDERED FOR THIS JOB:

http://utah.peopleadmin.com/postings/68938

 

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.

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University Of Utah