Job ID359569 LocationTwin Cities Job FamilyResearch-Nursing Full/Part TimeFull-Time Regular/TemporaryRegular Job Code3580N2 Employee ClassCivil Service About the Job The primary purpose of this position is to support a variety of research projects and portfolios in the Department of Pediatrics, including Neonatal Intensive Care Unit (NICU) clinical trials at the University of Minnesota Masonic Children's Hospital (UMMCH), and collaborating institutions according to regulatory requirements, institutional guidelines, and sponsor expectations. This position will also support clinical trials in other pediatric specialties requiring nursing expertise, as needed. Duties include performing patient assessments, administration of investigational agents, coordinating and acquisition of research samples, coordinating the enrollment of eligible patients, initiating new trials, extracting and reporting quality patient data, and responding to data queries. This position reports to the Research Director, but is accountable to the program leaders, the physician-investigators, and other members of the clinical research team. This position requires some flexibility regarding days & hours worked, which can be discussed based on research portfolio need. Responsibilities: Research Evaluations/Data Management (75%) Lead consent conversations with parents ensuring they understand what the research involves and how it differs from clinical care Continue to inform parents regarding research assessments providing education and transparency Utilize the nursing process and standards to safely perform protocol-specific procedures (Peapod, ERP, etc...) Administer medications and/or treatments as defined by the study protocol Research order entry in Epic, according to protocol Coordinate research subject's participation ensuring all protocol assessments are completed Act as information resource to University of Minnesota faculty and staff for protocol specific questions, including availability of trials, enrollment requirements, assessments, 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 samples Ensure timely and accurate data submission, engage with providers and investigators to ensure adequate source documentation is available with accurate interpretation and recording of data Education (10%) Educate University faculty and staff of our regulatory and research obligations in relation to program research activities Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care Regulatory (10%) Review of clinical research protocols, subject consent forms and other study documents, ensuring understandability Understanding of the regulatory process to ensure participant safety Prepare for and participate in site initiation visits, monitoring visits, program audits, etc. Administration (5%) Participate in Pediatric Clinical Research Services initiatives (workgroups, process improvement, quality assurance) Attend national meetings as appropriate Qualifications Required Qualifications: Associate or Bachelor's Degree in Nursing with current licensure to practice as an RN in the State of Minnesota BS degree in Nursing with at least 2 years of experience or a combination of related education and work experience to equal six years Preferred Qualifications: Clinical/Bedside nursing experience within the last 2 years Ability to prioritize patient safety, adjust to change and escalate appropriately Ability to work effectively with all members in the healthcare setting Detail-oriented with exceptional organizational, planning and problem-solving skills Computer proficiency and ability to navigate multiple software applications Demonstrated ability to meet deadlines and prioritize assignments Excellent written, verbal and interpersonal ski ls 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. NICU or Pediatric specific clinical/bedside experience Experience working with Epic (electronic medical record system) Awareness of clinical research purpose, regulations, methodologies and/or clinical trial coordination Experience with investigational drugs and/or devices About the Department At the University of Minnesota in the Department of Pediatrics, our experts, care teams and researchers are illuminating cures and advocating for changes that save young lives. Our ground-breaking treatments and programs are improving the lives of children who are ill or injured, and are becoming the standards of care for children across the country and around the world. The Pediatric Clinical Research Services program supports a variety of research projects and portfolios in the Department of Pediatrics. This includes supporting research in the Neonatology Division. The mission of the Neonatology Division is to provide exceptional and innovative care to infants requiring intensive care level support. These infants may have been born extremely premature, have complex diagnostic and surgical needs, and/or require long-term care and support. Our physician-investigators are committed to reducing mortality and morbidity during infancy, developing strategies to ameliorate disease processes, understanding mechanisms of development and improving quality of life during this formative period of life and throughout the continuum. The Pediatric Clinical Research Services program serves the University's research mission by providing comprehensive research support to faculty investigators conducting medical research in neonates, infants, children, adolescents, and young adults. We accomplish our mission by 1) developing competent professionals specialized in pediatric clinical research, 2) creating effective and efficient pathways for conducting compliant clinical research, and 3) fostering a participant-centric research culture. Benefits Working at the University At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work. The University also offers a comprehensive benefits package that includes: Competitive wages, paid holidays, and generous time off Continuous learning opportunities through professional training and degree-seeking programs supported by the Low-cost medical, dental, and pharmacy plans Healthcare and dependent care flexible spending accounts University HSA contributions Disability and employer-paid life insurance Employee wellbeing program Excellent retirement plans with employer contribution Public Service Loan Forgiveness (PSLF) Financial counseling services Employee Assistance Program with eight sessions of... For full info follow application link. The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.