Description:
The Division of Pediatric Critical Care at the University of Utah School of Medicine has an immediate opening for a Pediatric Project Manager II. This is an exciting opportunity to serve as a Project Manager for the NIH funded Utah Trials Innovation Center (TIC). The TIC is part of an initiative to create the Trial Innovation Network as part of the Clinical and Translational Science Award (CTSA) Program. This position provides opportunities to work with a high functioning, cutting edge team that will study, understand and improve multi-site translational research. This position requires a person with autonomy, creativity, and critical thinking skills.
The Pediatric Project Manager II independently manages and coordinates research network studies and trials at various clinical sites. Assists in the development of research projects, scientific study design, data interpretation, training of research site personnel, and maintains regulatory compliance, patient safety, and data quality. Monitors the conduct and progress of studies to ensure compliance with established protocols and study time lines. Licensed professionals may perform medical reviews and analyze or evaluate clinical data. This position provides the opportunity to travel for network committee meetings.
University of Utah Job ID# PRN14504B, Pediatric Critical Care
WORK SCHEDULE: Full time, 40 hours/week, Monday–Friday, 8:00 a.m. to 5:00 p.m.
COMPENSATION: $47,600 to $79,699 DOE. Strong benefit package including tuition reduction program, retirement and health plan options.
RESPONSIBILITIES:
1. Independently provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level.
2. Assures regulatory compliance for the data coordinating center.
3. Maintains research data files and regulatory documents for all clinical trial sites.
4. Identifies and creates queries to improve data capture and assists in developing methods to clarify/clean existing data.
5. Reviews site monitoring reports and discusses findings with Study Investigators and offers suggestions and solutions to problems, concerns, or recurrent trends or themes.
6. Assures that adverse events are reported to the sponsor.
7. Reviews site records for accuracy regarding test article accountability.
8. Develops study specific network guidelines and Standard Operating Procedures.
9. Organizes study trainings and gives presentations to employees and other research coordinators on good clinical practices and study procedure implementation.
10. Acts as liaison between study Investigators and sponsors to communicate and resolve issues.
11. Assumes considerable leadership responsibilities of studies throughout the network.
12. Provides feedback on study site performance, compliance, and data quality.
13. Makes recommendations regarding site disciplinary actions, which may result in site monitoring visits, suspension, or discontinuation of a study site.
14. Performs remote site monitoring activities independently.
15. Licensed professionals may be assigned medical reviews.
16. Must be able to perform the essential functions of a Level 1 Project Manager.
Qualifications:
Bachelor’s degree in a health science field, or equivalency (2 years related work experience may be substituted for 1 year of education). 4 years of clinical research experience that includes project management is also required. Experience with human subjects research, good leadership skills, and working knowledge of FDA, ICH, and other regulatory compliance are also required. Must have excellent interpersonal and communications skills, both oral and written. Must be proficient in Microsoft Office and possess the ability to learn new software programs such as electronic data capture software.
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/65679
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.