Description:
The Division of Pediatric Critical Care at the University of Utah School of Medicine has an immediate opening for a Pediatric Project Manager III. 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. Requires protocol development expertise and regulatory experience in working with Central IRBs. Autonomy, creativity, and critical thinking skills are strongly encouraged and welcomed.
The Pediatric Project Manager III independently manages and coordinates complex interventional network studies and trials at various clinical sites. Assists in the development of research projects, scientific study design, protocol development, data interpretation and analysis, 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 timelines. Provides mentoring and leadership for junior team members. Licensed professionals may perform medical reviews and analyze or evaluate clinical data.
University of Utah Job ID# PRN14506B, 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. Assists network clinical investigators and research coordinators with the development of scientific research projects and oversees protocol development.
2. Works with investigators to design data collection tools and other data elements.
3. Prepares, submits, and maintains regulatory documents and research correspondence.
4. Assesses quality patient safety issues related to the data and develops intervention plans as necessary.
5. Conducts site monitoring visits or assists with visits to clinical sites to ensure protocol and regulatory compliance, data quality, and patient safety.
6. Completes detailed reports of monitoring findings.
7. Analyzes and evaluates clinical data.
8. Licensed professionals may be assigned medical reviews.
9. Leads and mentors junior team members.
10. Assists Project Director with all orientation and training of new team members.
11. Must be able to perform the essential functions of level 1 and 2 Project Manager.
Qualifications:
Bachelor’s degree in a health science field, or equivalency, credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Certified Clinical Research Associate (CCRA) or other related certification, AND 6 years clinical research experience that includes project management. Knowledge of FDA, ICH, and other regulatory guidelines, experience in writing research materials, excellent leadership skills, as well as excellent interpersonal and communication skills are also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs.
Preference will be given to candidates having a Master’s degree in a health related 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.
Application Instructions:
PLEASE APPLY ONLINE THROUGH THE UNIVERSITY OF UTAH SYSTEM TO BE CONSIDERED FOR THIS JOB: http://utah.peopleadmin.com/postings/65683
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.