Job Duties/Responsibilities: •70% - Provide clinical research assistance and support to University Neurosurgery faculty performing clinical research, including their clinical research study teams. - Follow Good Clinical Practice (GCP) guidelines in the conduct, performance, and recording of clinical research. - Duties are determined by protocol-specific requirements and may include any research activity from protocol development through study closeout. The incumbent may assume responsibility for continuity of research participant care and follow the participant from beginning to completion of the study. - Facilitate the successful implementation of the IRB approved protocol; read and interpret clinical protocols; assess study related needs; evaluate feasibility; and provide input to facilitate implementation. - Identify potential risks and take steps to promote participant safety. - Identify interdisciplinary and facility resource needs and facilitate implementation. Prioritize protocol needs, determine priorities, identify potential risks and implement a plan to address risks. - Collaborate with other disciplines involved in the research process - Assist with development of clinical research protocol documentation - Demonstrate effective and efficient communication with study sponsors, monitors, department and University staff - Maintain accurate and complete study records, supplies, and time keeping tools. - Maintain a safe physical environment for the research participant(s). - Complete and maintain essential, source, and regulatory documents - Contribute to the efficiency and effectiveness of the research process by offering suggestions and participating as an active member of the research team - Participate in production of research publications or presentation of research data - Track time spent on each research study to facilitate effort reporting - Update Participant Tracking Forms in the organization's business system. - Track participant data in OnCore and/or REDCap. Document as required in EPIC. - Perform research procedures for the collection of meaningful research data. - In accordance with GCP and protocol, provide services, assessments, or interventions - Identify the appropriate personnel to perform direct and indirect research activities based on needs, condition, and potential for risk/harm, by evaluating the complexity of the activity and predictability of the outcome. - Continually evaluate the successful approach to protocol implementation in accordance with GCPs. - Evaluate compliance to protocol and systematically and continuously evaluate participant response to interventions, expected outcomes, and possible adverse reactions. - Manage subject participation in research protocol: -- Recruit potential participants -- Ensure informed consent and compliance with HIPAA requirements -- Determine participant eligibility, and maintain compliance with protocol eligibility requirements. -- Collect, and ship specimens for research, laboratory, or clinical testing as required -- Monitor participant responses to protocol defined treatments/interventions, and schedule required visits and tests. -- Evaluate laboratory and other findings to determine the presence of expected and unexpected participant reactions or outcomes -- Assess, troubleshoot, and report problems with data collection or other research processes. -- Obtain or confirm participant's consent to participate in research. Assess the participant's understanding of the research process, procedures and plan; implement and conduct participant and family education in response to identified needs. -- Under the supervision of the PI, report study/medical/test results for participants and/or families and report significant findings to the appropriate study staff.
• Act as liaison with institutional (MN Health, UMP, Medical School) and external (N2QOD) partners by: • 20%- Research support: serve as support for clinical research teams within the neurosurgery department. • 10% - Responsible for the interpretation of, application of, and compliance with federal regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as they relate to assigned research protocols.
All required qualifications must be documented on application material
Required Qualifications: • Bachelor’s degree in a health-related field plus 2 years of work experience in clinical research; or a combination of related education and work experience in clinical research totaling 6 years. • Experience in conducting and managing clinical research protocols and/or quality and safety improvement projects • Previous experience leading clinical research teams and supporting the professional development of clinical research staff. • Experience supporting a variety of research sponsors including federal grants and industry contracts. • Experience collaborating with key partners across an academic health system and University research community. • Demonstrate the ability to work in a complex, high energy environment, including excellent organization skills and attention to detail. • Strong communication skills, written and verbal. • Demonstrated/documented ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical research studies.
Preferred Qualifications: • Master’s degree in health or research related field • Research certification (such as CCRC or CCRP) • Familiarity with the University of Minnesota, M Health Fairview hospitals and clinics • Experience with EPIC, OnCore, REDCap • Clinical research, clinical trial, or research administration experience. • Certification in Project Management (ex. PMP). • Experience in data management and data analysis. • Experience in query development.
Internal Number: 339999
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.