Job Duties/Responsibilities Research Coordination (60%) • Duties are determined by protocol-specific requirements and may include any research activity from protocol development through study closeout. Responsible for continuity of research subject care and following the subject from beginning to completion of the study. • Facilitate the successful implementation of a protocol, read and interpret clinical protocols, assess needs, evaluate feasibility and provide input to facilitate implementation. • Identify potential risks and take steps to promote subject safety. Identify interdisciplinary and facility resource needs and facilitate implementation. Prioritize protocol needs, potential risks, determine priority problems and implement plan to address. • Perform research procedures for collection of meaningful research data. • Collaborate with other disciplines involved in the research process. • Demonstrate effective and efficient communication with study sponsors, monitors, departmental and M Health staff, healthcare team members, and collaborators at outside institutions. • Maintain accurate and complete research records, essential documents, and regulatory files. • Assist with, review, and track Institutional Review Board (IRB), regulatory, and FDA submissions. • Assist with protocol budget creation and tracking. • Assist with development of standard operating procedures and processes. • Track, order, and maintain adequate inventory of study supplies. • Contribute to the efficiency and effectiveness of the research process by offering suggestions and participating as an active member of the research coordination team. • Participate in production of research publications or presentation of research data. • Problem solve, delegate direct and indirect research activities to appropriate personnel based on needs, condition, and potential for risk/harm, complexity of the activity and predictability of the outcome.
Participant Recruitment and Clinical Coordination (40%) • Assist with recruiting participants into research studies, including building relationships with key clinical and community stakeholders • Respond to potential research participants’ inquires regarding research opportunities • Coordinate research participant visits and clinical logistics • Evaluate compliance to protocol and systematically and continuously evaluate subject response to interventions, expected outcomes, and adverse reactions. • Manage subject participation in HIV research protocols: o Participate in protecting the rights of the research subject. o Participate in recruitment of appropriate subjects o Determine eligibility, and maintain compliance with protocol requirements. o Collect, process and/or ship specimens, body fluids for research, laboratory or clinical testing as required often in repetitive and concise fashion so as to maintain integrity of processes across all subjects. o Monitor subject responses to protocol/treatment/interventions; schedule required visits and tests. Evaluate laboratory and other findings to determine the presence of expected and unexpected adverse reactions. o Assess, troubleshoot, and report problems with data collection or other research processes. Identify desired research subject outcomes, evaluate and monitor research subject's responses. o Confirm subject's consent to participate in research. Assess subject's understanding of research processes, procedures and plan, implement and conduct subject and family education in response to identified needs. Interpret study/medical results to families and /or health care staff and report significant findings to appropriate study staff.
All required qualifications must be documented on application materials.
Required Qualifications • BS/BA degree with at least 2 years of experience or a combination of related education and work experience to equal at least 6 years. • Knowledge of research design, protocols, and analysis as well as regulatory aspects of research protocols • Desires a career that supports and promotes clinical research. • Experience in the use of computer hardware and associated software. • Highly organized and detail-orientated • Flexibility with work schedule to accommodate subject visits. • Strong critical thinking skills • Ability to work independently, make decisions, problem solve, and prioritize the simultaneous coordination of multiple clinical studies.
** Proof of non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza are required.
Preferred Qualifications • Two years of clinical research coordination experience. • Certified as a Clinical Research Coordinator, or qualified to sit for the certification exam. • Familiarity with the University of Minnesota, University of Minnesota Medical Center-Fairview hospital and clinics • Experience with EPIC and OnCore • Experience prioritizing among competing deadlines, task, and projects • Experience with HIV research
Internal Number: 336670
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.