The primary purpose of this position is to support clinical research projects in a variety of pediatric specialties according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, coordinating the enrollment of eligible patients, supporting research evaluations and measurements, extracting and reporting quality patient data and tissue samples, and responding to data queries. This position reports to the Research Project Manager, but is accountable to the physician-investigators, program leaders, and members of the clinical research team.
Research Project Coordination (60%)
* Support a large and complex portfolio of research projects across multiple therapeutic areas that have complex operational logistics, including multi-site, multi-location trials that require advanced coordination skills
* Coordinate patient participation in clinical research, including: Screening and recruiting patients and families, Ensuring study eligibility and enrollment, and Scheduling and conducting research visits
* Data management for multiple projects, including: Data collection and entry into databases, Ensuring data quality, Supporting the PI and Developer in database development
* Specimen management for multiple projects, including: Facilitating the collection of research specimens during routine clinical procedures, Ensuring high quality processing of research specimens, and Coordinating timely and compliant shipment of research specimens to research laboratories
* Be a resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
* Engage with the research team 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%)
* Complete regulatory tasks as assigned
* Support the completion of required regulatory documentation
* 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 clinical research studies as assigned 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
* Facilitate new project development and start-up activities
* Initiate and lead quality improvement projects, and contribute to departmental and program initiatives
* Ensure accurate project time tracking
* Facilitate Pre-award and Post-award grant administration
* Attends national and study meetings as appropriate
* 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
* Mentor and train program junior staff as assigned
*BA/BS in a scientific or health related field and 4 years research experience, OR advanced degree plus 2 years research experience, OR a combination of education and experience in research to equal to 8 years
*Experience working with patients and families, preferably within a hopsital setting and/or pediatric populations
*Experience with computerized data management in a health-related setting
*Demonstrated data management skills, including data collection, generating reports, and ensuring data quality
*Computer proficiency and ability to navigate multiple software applications.
*Detail-oriented with exceptional organizational, planning and problem-solving skills
*Ability to work independently, as a part of a team and with changing priorities
*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 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.
*Advanced degree: MPH, MSW or similar
*Experience with OnCore CTMS and Epic electronic medical record system
*Experience with pediatric populations
At University of Minnesota Department of Pediatrics, our experts, care teams and researchers are illuminating cures that save young lives. Our ground-breaking treatments are improving the lives of children who are ill or injured, and are becoming the standard of care for children across the country and around the world.
The Pediatric Clinical Research Services program serves the University's research mission by providing comprehensive research support to faculty investigators conducting medical research in neonates, infants, children, adolescents, and young adults. We accomplish our mission by 1) developing competent professionals specialized in pediatric clinical research, 2) creating effective and efficient pathways for conducting compliant clinical research, and 3) fostering a participant-centric research culture.
Working at the University
At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.
The University also offers a comprehensive benefits package that includes:
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