Pediatric Project Manager III

Job Summary
Job Summary The Utah Data Coordinating Center DCC has an immediate opening for a Clinical Project Manager III . Come be part of the Utah DCC where we are the expert architects of missioncritical clinical research. This position offers opportunities to work with high functioning cuttingedge teams that study understand and improve multisite research. Bring your background in strong clinical research protocol development regulatory and single IRB experience to the Utah DCC . Autonomy creativity and critical thinking skills are strongly encouraged. Our clinical project managers manage multicenter clinical trials for both pediatrics and adults coordinate network consultations and manage single IRB activities. As a Clinical Project Manager you are at the center of each research project through working directly with sites investigators and researchers. The ability to manage local and virtual teams collaborate with network participants is a must. In this role you may support more than one research network and/or research project. Projects include pediatric emergency department trials funded by the PECARN Network the Network of Pediatric Multiple Sclerosis Centers NPMSC and the Guthy Jackson Charitable Foundation a research network addressing Neuromyletis Optica. Our projects also include the NIH funded HEAL (Helping End Addiction Long Term) Pain Management Effectiveness Research Network ERN . You may also support new exciting incoming research projects through our business development core. The Utah DCC offers a career ladder for Clinical Project Managers and provides growth and professional development opportunities. To learn more about the Utah DCC visit The University of Utah offers a comprehensive benefits package including: Excellent health care coverage at affordable rates 14.2 retirement contributions that vest immediately Generous paid leave time 11 paid Holidays per year 50 tuition reduction for employee spouse and dependent children Flex spending accounts Free transit on most UTA services Employee discounts on a variety of products and services including cell phones & plans entertainment health and fitness restaurants retail and travel Professional development opportunities Additional benefits information is available at Functions Assists network clinical investigators and research coordinators with the development of scientific research projects and oversees protocol development Works with investigators to design data collection tools and other data elements. Prepares submits and maintains regulatory documents and research correspondence Assesses quality patient safety issues related to the data and develops intervention plans as necessary Conducts site monitoring visits or assists with visits to clinical sites to ensure protocol and regulatory compliance data quality and patient safety Completes detailed reports of monitoring findings Analyzes and evaluates clinical data Licensed professionals may be assigned medical reviews Leads and mentors junior team members Assists Operations Leader with all orientation and training of new team members Must be able to perform the essential functions of level 1 and 2 Project Managers. Problem Solving This position makes independent decisions regarding data issues study procedures and protocol issues as well as recognizing and resolving protocol deviations. It provides input on site performance compliance and data quality. This position also makes recommendations for disciplinary action which may result in a site monitoring visit suspension or discontinuation of a study site. Determines when to involve Study Principal Investigator or DCC Principal Investigator about issues/concerns that arise at the study sites and develops methods to resolve data discrepancies. Comments Remote Work: This is a remote work position with the ability to travel and work in the office setting as required. Certain meetings on campus and conferences may be required to attend inperson. This position requires expertise and interpretation of laws federal regulations ICH guidelines and Good Clinical Practice guidelines to provide direction/guidance/supervision to study sites. Ensures the sites are compliant with protocol federal regulations ICH guidelines Good Clinical Practice guidelines and local IRB requirements. This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to the job.

Minimum Qualifications
Bachelors degree in a health science field or equivalency (one year of education can be substituted for two years of related work experience) 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 Masters 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.