The primary purpose of this position is to support numerous new clinical research projects 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 Research Project Manager, but is accountable to the physician-investigators, program leaders, and members of the clinical research team.
Responsibilities: Research Project Coordination (60%) • Independently manage a large and complex portfolio of research projects. • Data management for multiple pediatric endocrinology projects, including: o Database development o Data collection o Ensuring data quality o Developing summary reports • Inform and coordinate the development of a long-term follow-up research project in pediatric endocrinology • 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, 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 severe adverse events • Contribute to the production of research publications or presentations of research data
Research Regulatory Management (25%) • Ensure overall regulatory compliance for a large and/or complex portfolio of research projects • Serve as the primary contact for the completion of required regulatory documentation • 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
Administration (10%) • Facilitate new project development and start-up activities • Support quality improvement initiatives • Facilitate Pre-award and Post-award grant administration • Attends national and study meetings as appropriate
Education (5%) • Support the training and mentoring of CRCs within the program and across 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***
• 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 • At least 1-year experience conducting clinical research, preferably at the University of Minnesota • Experience with patient contact, preferably with pediatric patients and their families • Experience recruiting to clinical research studies • Experience with computerized data management in a health-related setting, including experience with electronic medical records • 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 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 • Master’s Degree is related field • Research database development and management • Specimen management experience, including processing human samples and shipping per regulations • Experience with Epic electronic medical record system
Internal Number: 335034
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.