Act as information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
Conduct participant recruitment and screening for available trials and studies.
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 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 severe adverse events
Contribute to the production of research publications or presentations of research data
Research Regulatory Management (15%)
Prepare regulatory approval applications; respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained. Track all regulatory review submissions to ensure deadlines are met.
In collaboration with the PI, interpret study protocols and develop consent form documents 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
Provide regulatory guidance and direction to all members of the research team to ensure compliance with applicable policies, procedures, and regulations
Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
Report Unanticipated Problems according to University policy
Facilitate new project start-up
Support quality improvement initiatives
Attends national and study meetings as appropriate
Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
The primary purpose of this position is to support clinical trials within pediatric nephrology, specifically the Alport Syndrome research program. 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 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.
All required qualifications must be documented on application materials.
BA/BS in a scientific or health related field and 2 years clinical research experience, OR a combination of education and experience in clinical research to equal to 6 years
Experience in an academic medicine or 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.
Certification as a CCRP or CCRC
Certified Medical Assistant or similar experience
Experience with Epic electronic medical record system
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.