Description:
Under the guidance of the Program Manager, manages and coordinates research network studies and trials at various clinical sites. Monitors the conduct and progress of studies to ensure compliance with established protocols and study timelines. May assist in the development of research projects, scientific study design, data interpretation, training of research site personnel, and maintain regulatory compliance, patient safety, and data quality.
Licensed professionals may perform medical reviews and analyze or evaluate clinical data.
University of Utah Job ID# PRN14983B, Pediatric Critical Care
WORK SCHEDULE: Full-time, 40 hours/week, Monday–Friday, 8:00 a.m. to 5:00 p.m.
COMPENSATION: $39,300–$56,000 DOE. Strong benefit package including tuition reduction program, retirement and health plan options.
RESPONSIBILITIES:
1. Under the guidance of the Program Manager, provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level.
2. Prepares, submits, and maintains IRB, FDA, and other regulatory documents and research correspondence.
3. Reviews site files and records for completeness, accuracy, consistency and compliance; identifies deficiencies or discrepancies and facilitates their resolution.
4. Assures that adverse events are reported to the sponsor.
5. Works with programmers to develop and test databases and other collection tools.
6. Analyzes incoming data to identify trends, problems, or other issues.
7. Prepares and interprets reports and queries for Investigators and Research Coordinators, which include, but not limited to monthly enrollment reports, reports of various data elements, query reports, etc.
8. Ensures that captured data is accurate and corrects erroneous or conflicting data.
9. Communicates with study sites frequently to discuss and follow-up on data issues and troubleshoots possible solutions.
10. Works with site monitors to ensure protocol and regulatory compliance, data quality, and patient safety.
11. Performs remote monitoring of site data in coordination with appropriate personnel.
12. Attends required meetings and conferences as appropriate.
13. Licensed professionals may be assigned medical reviews.
Qualifications:
Bachelor’s degree in a health science field, or equivalency AND 2 years of clinical research experience. Experience with human subjects research preferred. Must have excellent interpersonal and communication skills, both oral and written. Must be proficient in Microsoft Office and possess the ability to learn new software programs.
Credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or other related certification is highly preferred, along with experience in the specific clinical research area.
Depending on the area of assignment, current medical licensure may be preferred. Licensed professionals must have a current registration or licensure in the State of Utah as required by the profession.
This position is not responsible for providing patient care.
Application Instructions:
PLEASE APPLY ONLINE THROUGH THE UNIVERSITY OF UTAH SYSTEM TO BE CONSIDERED FOR THIS JOB: http://utah.peopleadmin.com/postings/67669
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.