Research - Laboratory/Non-Laboratory, Staff/Administrative
The primary purpose of this position is to aid university medical school faculty performing clinical research in the understanding and treatment of Sarcoidosis and acute respiratory distress syndrome. Duties are determined by protocol-specific requirements and may include any research activity from protocol development through, interaction with IRB, data abstraction .This position involves working with adult patients.
Essential Functions or Job Duties:
• Aid 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 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. • Interact with study monitoring individuals and the cystic fibrosis and COPD center personnel. • 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. • 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. • Assist the PI in reporting SAE’s and DSM reports. • Manage subject participation in research protocol: • Recruit potential subjects • Participate in protecting the rights of the research subject via execution of informed consent and compliance with HIPAA requirements • Determine subject eligibility, and maintain compliance with protocol eligibility requirements. • 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. • Monitor subject 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 subject reactions or outcomes • Assess, troubleshoot, and report problems with data collection or other research processes. • 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.
The employer reserves the right to change or assign other duties to this position.
Required Qualifications (must be mentioned on application/resume): • Bachelor’s degree or a combination of related education and work experience to equal four years. • Flexibility with work schedule to accommodate subject visits and biospecimen collection. • Able to enroll patients, administer surveys, enter data spreadsheets / REDCap, perform quality checks on data, collect data from clinical charts. • 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 • Previous Clinical or Clinical Work Experience • Familiarity with patient enrollment into clinical trials and consenting process. • Training in simple statistical analysis.
Internal Number: 331244
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.