Research Support - Laboratory/Non-Laboratory, Staff/Administrative
The primary purpose of this position is to support clinical research projects in the Department of Medicine according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties are determined by protocol-specific requirements and may 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 Director of Clinical Research Administration, but is accountable to the physician-investigators, program leaders, and members of the clinical research team. Essential Functions or Job Duties (100%) Provide clinical research assistance to University faculty performing clinical research: • 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 subject care and follow the subject 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 subject 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 subject(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 • Report work time on an electronic time card • Update Subject Tracking Forms in the organization's business system. • 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 subject response to interventions, expected outcomes, and possible adverse reactions. • Manage subject participation in research protocol: o Recruit potential subjects o Participate in protecting the rights of the research subject via execution of informed consent and compliance with HIPAA requirements o Determine subject eligibility, and maintain compliance with protocol eligibility requirements. o Collect, and ship specimens for research, laboratory, or clinical testing as required, often in repetitive and concise fashion so as to maintain integrity across all subject visits. o Monitor subject responses to protocol defined treatments/interventions, and schedule required visits and tests. o Evaluate laboratory and other findings to determine the presence of expected and unexpected subject reactions or outcomes o Assess, troubleshoot, and report problems with data collection or other research processes. o Obtain or confirm subject's consent to participate in research. Assess the subject's understanding of the research process, procedures and plan; implement and conduct subject and family education in response to identified needs. o Under the supervision of the PI, report study/medical/test results for subjects and/or families and report significant findings to the appropriate study staff.
All required qualifications must be documented on application materials.
Required Qualifications • Bachelor’s degree in a health related field plus 2 years of work experience in research; or a Certified Medical Assistant plus 4 years of work experience in research; or a combination of related education and work experience in research totaling 6 years • Experience in the use of computer hardware and associated software. • Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies. • Possess excellent interpersonal communication skills with patients and healthcare professionals; verbal and written • Ability to follow strict protocols with utmost ethical standards **Proof of non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza are required.
Preferred Qualifications • Familiarity with the University of Minnesota, University of Minnesota Medical Center, Fairview hospital and clinics • Experience with EPIC or other electronic medical records systems • Phlebotomy skills • Certification as a Clinical Research Coordinator, or qualified to sit for the for the certification exam
Internal Number: 337810
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.