Research Support - Laboratory/Non-Laboratory, Staff/Administrative
The primary purpose of this position is to support clinical research within the Division of Pediatric Nephrology. The Clinical Research Coordinator facilitates the conduct of research according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new studies, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, and responding to data queries. This position reports to the Clinical Research Program Director, but is accountable to the program leaders, the physician-investigators, and members of the clinical research team.
Responsibilities Clinical Research Conduct & Facilitation (75%)
Coordinate all study-related activities, including participant recruitment, enrollment, study visits, data and specimens, and sponsor visits
Act as information resource 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, ensuring the appropriate recording of adverse events, and timely acquisition of research tissue.
Ensure timely and accurate data collection and submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.
Process human specimens per protocol requirements, coordinate shipping as needed
Facilitate the timely review and reporting of adverse reactions and severe adverse events
Conduct data abstraction for chart review studies
Assist investigators with literature searches
Contribute to the production of research publications or presentations of research data
Research Regulatory Management (20%)
Support the maintenance of regulatory binders and required documentation as directed
Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
Partner with Regulatory Specialist to ensure timely and complete regulatory submissions (IRB, HRPP, etc.)
Report Unanticipated Problems according to University policy
Education and Administration (5%)
Educate others of our regulatory and research obligations in relation to our clinical research activities
***All required qualifications must be documented in application materials***
BA/BS in a scientific or health related field and experience in a medical setting, OR a combination of education and experience in clinical research to equal to 4 years
Experience working in an academic medicine or pediatric acute medical setting
Experience with computerized data management in a healthcare setting, including electronic medical records
Demonstrated ability to identify data for abstraction
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 Good Clinical Practices (GCPs), and federal regulations related to clinical research
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.
Knowledge of clinical research
Experience with Epic
Experience with patient care / contact
Internal Number: 333600
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.