The primary purpose of this position is to support clinical research studies within pediatrics across multiple specialties. This position will primarily support clinical research related to COVID-19 and Pediatric Critical Care, but will support other programs as needed.. The Clinical Research Coordinator facilitates the conduct of research according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and biological samples, and responding to data queries. This position reports to the Research Project Manager, but is accountable to the program leaders, the physician-investigators, and members of the clinical research team.
Research Project Coordination (70%) • Coordinate a large and complex portfolio of research projects • Coordinate patient participation in clinical research, including: o Screening and recruiting patients and families o Ensuring study eligibility and enrollment o Scheduling and conducting research visits • Data management for multiple projects, including: o Data collection and entry into databases o Ensuring data quality o Supporting the PI and Developer in database development • Specimen management for multiple projects, including: o Coordinating the collection of research specimens during routine clinical procedures o Ensuring high quality processing of research specimens o Managing timely and compliant shipment of research specimens to research laboratories • Provide information to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc. • Engage with investigators in verifying subject eligibility, facilitating subject enrollments, and ensuring compliant completion of research activities • Ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts • Facilitate the timely review and reporting of adverse reactions and serious adverse events
Research Regulatory Management (20%) • Support regulatory compliance for a large and complex portfolio of research projects • Support the completion of required regulatory documentation • Support regulatory staff in preparing regulatory approval applications; responding to stipulations, and ensuring IRB approval for research activities • In collaboration with the research team, interpret study protocols and inform the development of consent forms and other participant materials needed for each clinical research study • Maintain regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time • Prepare for and participate in site initiation visits, monitoring visits, program audits, etc. • Report Unanticipated Problems according to University policy
Administration (5%) • Facilitate new project development and start-up activities • Support quality improvement initiatives • Facilitate Pre-award and Post-award grant administration • Attend national and study meetings as appropriate
Education (5%) • Support the training and mentoring of CRCs within the program and across the Department of Pediatrics • Educate University faculty and staff of our regulatory and research obligations in relation to our clinical research activities • Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
***All required qualifications must be documented on application materials***
Required Qualifications • BA/BS in a scientific or health related field and 2 years research experience, OR a combination of education and experience in research to equal 6 years • Experience working with patients and families, preferably within a hospital setting and/or pediatric populations • Experience with computerized data management in a health-related setting, including electronic medical records, preferably EPIC • Demonstrated data management skills, including data collection, data entry and quality control • Computer proficiency and ability to navigate multiple software applications • Detail-oriented with exceptional organizational, planning and problem-solving skills • Ability to work independently, as well as part of a team • Ability to adapt to changing priorities based on most critical need • Demonstrated ability to maintain deadlines and prioritize assignments • Excellent written, verbal and interpersonal skills • Knowledge of federal regulations related to research with human subjects and protected health information • Ability to work flexible work hours, including occasional evening and weekends • During a typical 8 hour shift, a person in this position may be required to stand up to 2.5 hours, walk up to 2.5 hours (including stairs), reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level.
Preferred Qualifications • Relevant research certification, such as CCRP or CCRC • Certified Medical Assistant or similar experience • Experience recruiting subjects to research studies • Specimen management experience including processing human samples and shipping per regulations • Regulatory management experience including IRB submissions and regulatory binder maintenance
Internal Number: 337821
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.