Pediatric Project Manager II

Job Summary
Job Summary The Utah Data Coordinating Center DCC has an immediate opening for a Clinical Project Manager II. 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 (www.pecarn) 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 http://uofuhealth/UtahDCC 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 www.hr.utah/benefits

Responsibilities
Essential Functions: Independently provides oversight for all aspects of study conduct regulatory compliance and record keeping processes at the site or institution level. Assures regulatory compliance for the data coordinating center Maintains research data files and regulatory documents for all clinical trial sites. Identifies and creates queries to improve data capture and assists in developing methods to clarify/clean existing data Reviews site monitoring reports and discusses findings with Study Investigators and offers suggestions and solutions to problems concerns or recurrent trends or themes Assures that adverse events are reported to the sponsor Reviews site records for accuracy regarding test article accountability (if applicable) Develops study specific network guidelines and Standard Operating Procedures Organizes study trainings and gives presentations to employees and other research coordinators on good clinical practices and study procedure implementation Acts as liaison between study Investigators and sponsors to communicate and resolve issues Assumes considerable leadership responsibilities of studies throughout the network Provides feedback on study site performance compliance and data quality Makes recommendations regarding site disciplinary actions which may result in site monitoring visits suspension or discontinuation of a study site Performs remote site monitoring activities independently Licensed professionals may be assigned medical reviews Must be able to perform the essential functions of a Level 1 Project Manager 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. The 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). 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. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.