University of Minnesota
Clinical Research Nurse 3
University of Minnesota, Minneapolis, Minnesota, United States, 55400
Apply for Job Job ID 362160Location Twin CitiesJob Family Research-NursingFull/Part Time Full-TimeRegular/Temporary RegularJob Code 3580N3Employee Class Civil ServiceAdd to Favorite Jobs Email this JobAbout the Job
JOB SUMMARYThe Research Nurse III is responsible for providing nursing technical expertise and overall execution of phase I - III clinical trials, with an emphasis on complex cell, gene and immunotherapy trials. This requires multidisciplinary skills directed towards clinical patient management and safety, and providing protocol-specific education to research participants and research staff. The incumbent will be expected to follow Good Clinical Practice (GCP) and all organizational policies and procedures for patient safety and data integrity, including but not limited to the Institutional Review Board (IRB), Food & Drug Administration (FDA), Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines.SPECIFIC RESPONSIBILITIESStudy Coordination & Data Management (85%)Utilizes nursing education to contribute to study start-up activities, including site initiation visits, protocol review of feasibility and suggestions for revision, study and clinical staff training.Provide nursing expertise to interpret and operationalize the research protocol.Collaborates with PI and study team to recruit, screen and enroll study participants.Executes study-required procedures in collaboration with clinical staff.Educates patients and clinical staff through the duration of the study regarding the treatment plan, anticipated side effects, and monitoring guidelines/follow-up.Maintains accurate source documentation, including documentation of research visits in the EMR (e.g. consent/re-consent, adverse events, concomitant medications, protocol-related education, etc.).Coordinates and maintains a tracking system for patient visits, protocol-required data collection and other protocol procedures.Identifies and reports serious adverse events, stopping rules and dose limiting toxicities, and protocol deviations, within institutional and sponsor required timelines.Troubleshoots problems in the development and implementation of protocol procedures.Participates in visits with sponsors, monitors and other key collaborators, including site initiation visits, interim monitoring visits and closeout visits.Coordinates with Investigational Drug Services (IDS), BioNet, clinical staff, and other departments across campus to deliver drug, collect specimens, and execute the study visits according to protocol.Works as a member of the study team with positive and timely written and verbal communication, including sharing information up, down and laterally.Lead Activities (15%)Mentors and trains new staff, providing task level guidance to Research Nurses I & II.Serves as subject matter experts in key CTO processes, including audit preparation and conduct.Manages additional workload during staff changes.
Qualifications
All required qualifications must be documented on application materialsREQUIRED QUALIFICATIONSBA/BS degree in Nursing and 4 years of experience OR a combination of education and experience equivalent to 8 years.At least 2 years of clinical research experience.Current license to practice as a Registered Nurse in the State of Minnesota.Experience with Microsoft Office.Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies.Possess excellent communication skills; verbal and written.Flexibility with work schedule to accommodate subject visits.Proof of non-active tuberculosis and immunization for (or resistance to) measles, mumps, rubella, Hepatitis B, and pertussis (as well as any other requirements per Fairview Research Administration).PREFERRED QUALIFICATIONSExperience with EPIC.Familiarity with the University of Minnesota and MHealth Hospitals and Clinics.Experience with OnCore or equivalent clinical trials management system.
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 offContinuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit ProgramLow-cost medical, dental, and pharmacy plansHealthcare and dependent care flexible spending accountsUniversity HSA contributionsDisability and employer-paid life insuranceEmployee wellbeing programExcellent retirement plans with employer contributionPublic Service Loan Forgiveness (PSLF) opportunityFinancial counseling servicesEmployee Assistance Program with eight sessions of counseling at no costEmployee Transit Pass with free or reduced rates in the Twin Cities metro areaPlease visit the Office of Human Resources website for more information regarding benefits.How To Apply
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.Diversity
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.eduEmployment Requirements
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.About the U of M
The University of Minnesota, Twin Cities (UMTC)The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).
JOB SUMMARYThe Research Nurse III is responsible for providing nursing technical expertise and overall execution of phase I - III clinical trials, with an emphasis on complex cell, gene and immunotherapy trials. This requires multidisciplinary skills directed towards clinical patient management and safety, and providing protocol-specific education to research participants and research staff. The incumbent will be expected to follow Good Clinical Practice (GCP) and all organizational policies and procedures for patient safety and data integrity, including but not limited to the Institutional Review Board (IRB), Food & Drug Administration (FDA), Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines.SPECIFIC RESPONSIBILITIESStudy Coordination & Data Management (85%)Utilizes nursing education to contribute to study start-up activities, including site initiation visits, protocol review of feasibility and suggestions for revision, study and clinical staff training.Provide nursing expertise to interpret and operationalize the research protocol.Collaborates with PI and study team to recruit, screen and enroll study participants.Executes study-required procedures in collaboration with clinical staff.Educates patients and clinical staff through the duration of the study regarding the treatment plan, anticipated side effects, and monitoring guidelines/follow-up.Maintains accurate source documentation, including documentation of research visits in the EMR (e.g. consent/re-consent, adverse events, concomitant medications, protocol-related education, etc.).Coordinates and maintains a tracking system for patient visits, protocol-required data collection and other protocol procedures.Identifies and reports serious adverse events, stopping rules and dose limiting toxicities, and protocol deviations, within institutional and sponsor required timelines.Troubleshoots problems in the development and implementation of protocol procedures.Participates in visits with sponsors, monitors and other key collaborators, including site initiation visits, interim monitoring visits and closeout visits.Coordinates with Investigational Drug Services (IDS), BioNet, clinical staff, and other departments across campus to deliver drug, collect specimens, and execute the study visits according to protocol.Works as a member of the study team with positive and timely written and verbal communication, including sharing information up, down and laterally.Lead Activities (15%)Mentors and trains new staff, providing task level guidance to Research Nurses I & II.Serves as subject matter experts in key CTO processes, including audit preparation and conduct.Manages additional workload during staff changes.
Qualifications
All required qualifications must be documented on application materialsREQUIRED QUALIFICATIONSBA/BS degree in Nursing and 4 years of experience OR a combination of education and experience equivalent to 8 years.At least 2 years of clinical research experience.Current license to practice as a Registered Nurse in the State of Minnesota.Experience with Microsoft Office.Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies.Possess excellent communication skills; verbal and written.Flexibility with work schedule to accommodate subject visits.Proof of non-active tuberculosis and immunization for (or resistance to) measles, mumps, rubella, Hepatitis B, and pertussis (as well as any other requirements per Fairview Research Administration).PREFERRED QUALIFICATIONSExperience with EPIC.Familiarity with the University of Minnesota and MHealth Hospitals and Clinics.Experience with OnCore or equivalent clinical trials management system.
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 offContinuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit ProgramLow-cost medical, dental, and pharmacy plansHealthcare and dependent care flexible spending accountsUniversity HSA contributionsDisability and employer-paid life insuranceEmployee wellbeing programExcellent retirement plans with employer contributionPublic Service Loan Forgiveness (PSLF) opportunityFinancial counseling servicesEmployee Assistance Program with eight sessions of counseling at no costEmployee Transit Pass with free or reduced rates in the Twin Cities metro areaPlease visit the Office of Human Resources website for more information regarding benefits.How To Apply
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.Diversity
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.eduEmployment Requirements
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.About the U of M
The University of Minnesota, Twin Cities (UMTC)The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).