Description:
The Clinical Trials Office at the University of Utah, School of Medicine has an immediate opening for a Clinical Research Coordinator to provide support to multiple divisions within the University. This position is responsible for coordinating the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. The position will also oversee research studies and mentor junior research staff in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.
University of Utah Job ID# PRN14943B, Clinical Trials Office
WORK SCHEDULE: Full time, 40 hours/week, Monday–Friday, 9:00 a.m. to 5:30 p.m. Some weekends and after hours required.
COMPENSATION: $39,300 to $64,349/year DOE. Strong benefit package including tuition reduction program, retirement and health plan options.
RESPONSIBILITIES:
1. Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
2. Disseminates information about the protocol to junior research staff.
3. Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
4. Coordinates with data managers to monitor participant progression throughout study and conduct evaluation at end of study.
5. Recognizes, tracks and reports adverse events and protocol deviations.
6. Prepares for and coordinates site visits made by sponsors or federal agencies during the course of and at the close of the study.
7. Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
8. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
9. Completes ongoing training on techniques of clinical research coordination and practices, FDA Good Clinical Practices (GCP), and clinical research standard operating procedures to ensure compliance with policy and procedure, research sponsors and Federal rules and regulations.
10. Assures proper laboratory samples are collected and results reported to the proper entities.
11. Assists the Principal Investigator in the development of study materials.
Qualifications:
QUALIFICATIONS: Bachelor’s degree in a health sciences or related field with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required. Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
PREFERENCES: Four years of professional clinical research experience strongly preferred. Current CCRC or equivalent certification preferred.
Application Instructions:
PLEASE APPLY ONLINE THROUGH THE UNIVERSITY OF UTAH SYSTEM TO BE CONSIDERED FOR THIS JOB:
http://utah.peopleadmin.com/postings/67464
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.