Research - Laboratory/Non-Laboratory, Staff/Administrative
Research Facilitation (75%) • Act as information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc. • Assist with 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 tissues. • Support effective specimen management, including preparing kits, processing specimens, preparing shipments, tracking inventory, etc. • 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
Regulatory (15%) • Assist with the preparation of regulatory applications, consent forms, etc. Track regulatory review submissions to ensure deadlines are met. • Support the maintenance of regulatory binders and required documentation for each clinical research study 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
Administration (5%) • Facilitate new project development • Support quality improvement initiatives • Attends national and study meetings as appropriate
Education (5%) • 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
Required Qualifications: • 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 with computerized data management; 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 • 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.
Preferred Qualifications: • Certified Medical Assistant or similar experience • Experience with patient care / contact • Experience abstracting and reporting medical data for clinical research • Experience handling human specimens
Internal Number: 340570
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.