The primary purpose of this position is to support numerous clinical research projects in neonatology and other 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.
Responsibilities Research Project Coordination (70%)
Coordinate a large and complex portfolio of research projects
Coordinate patient participation in clinical research, including:
Screening and recruiting patients and families
Ensuring study eligibility and enrollment
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: Coordinating the collection of research specimens during routine clinical procedures, Ensuring high quality processing of research specimens, 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 (30%)
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
***All required qualifications must be documented on application materials***
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 at least 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.
Relevant research certification, such as CCRP or CCRC
Certified Medical Assistant or similar experience
Applicable advanced degree plus at least 1 year research 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: 336137
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.