Research - Laboratory/Non-Laboratory, Staff/Administrative
Clinical Research Conduct & Facilitation (90%) • 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 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 (5%) • Partner with Regulatory Specialist to ensure regulatory binders compliance for assigned studies • Prepare for and participate in site initiation visits, monitoring visits, program audits, 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 • 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 a clinical research study for patients with juvenile arthritis living in Minnesota. This position will coordinate all aspects of the study including outreach and recruitment, enrollment and facilitating specimen collection. Additionally this position will support other studies in the Division of Pediatric Rheumatology, Allergy and Immunology according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include recruiting, obtaining informed consent, obtaining needed specimens, and reporting quality patient data. This position reports to the Research Project Manager, 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
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 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 • 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: • Knowledge of clinical research, Good Clinical Practices (GCPs) and federal regulations related to clinical research • Experience with Epic or other electronic medical record system • Experience with patient care / contact
Internal Number: 340151
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.