Pediatric Project Manager I

The University of Utah • Salt Lake, UT

16d • Remote

About The Position

The Utah Data Coordinating Center ( DCC ) has an immediate opening for a Clinical Project Manager I. Come be part of the Utah DCC where we are the expert architects of mission-critical clinical research. This position offers opportunities to work with high functioning, cutting-edge teams that study, understand and improve multi-site 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.org), 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.org/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.edu/benefits

Requirements

• Bachelor’s degree in a health science field, or equivalency (one year of education can be substituted for two years of related work experience) AND 2 years of clinical research experience.
• 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.

Nice To Haves

• Experience with human subjects research preferred.
• 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.

Responsibilities

• Under the guidance of the Operations Leader, provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level
• Prepares, submits, and maintains IRB , FDA , and other regulatory documents and research correspondence. Knowledge of sIRB practices
• Reviews site files and records for completeness, accuracy, consistency and compliance; identifies deficiencies or discrepancies and facilitates their resolution
• Assures that adverse events are reported to the sponsor
• Works with programmers to develop and test databases and other collection tools
• Analyzes incoming data to identify trends, problems, or other issues
• 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.
• Ensures that captured data is accurate and corrects erroneous or conflicting data
• Communicates with study sites frequently to discuss and follow-up on data issues and troubleshoots possible solutions
• Works with site monitors to ensure protocol and regulatory compliance, data quality, and patient safety
• Performs remote monitoring of site data in coordination with appropriate personnel
• Attends required meetings and conferences as appropriate
• Licensed professionals may be assigned medical reviews
• May provide input on site performance, compliance and data quality

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees