Job ID359626 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P4 Employee ClassCivil Service About the Job Required Qualifications: BA/BS degree and at least five years of experience, or an advanced degree and at least three years of experience, or a combination of education and experience totaling at least 9 years. The purpose of this role is to facilitate the initiation of a new clinical trial through the start-up process to enrollment. This person will ensure a timely start-up for new clinical trials, as well and facilitate changes needed to studies already conducted in the LCRU. This person would work closely with the whole research team: research staff, Investigators, IRB, and finance. They will work closely with the Director to manage the Cardiology research portfolio. In addition, this position will help develop budgets, oversee invoicing, provide regular project and portfolio reporting updates and provide back-up to the IRB specialist. The successful candidate will be a self-starter with excellent people skills and the ability to manage multiple priorities and deadlines with changes as requests come through. Responsibilities: Study Set-Up & Ongoing Study Management (35%) 1. Assists investigators by providing strategic and operational expertise to grant applications, IRB submission, budgets and other clinical and translational research processes. 2. Serves as a primary information and training resource for staff and partners related to the study start-up, OnCore, Florence, e-consent and other internal required systems. 3. Manages project set-up in OnCore and facilitates updates, as needed. Works closely with IRB specialist, finance, and study coordinator to efficiently move a study through the start-up process. 4. Work with research team and outside partners to develop pricing and initial budget needs. 5. Attend start-up meetings for calendar builds and study execution. 6. Attend meetings that relate to the systems for study start up and management to represent the department. 7. Conducts study progress reporting, manages enrollment progress reports & portfolio reporting Regulatory Maintenance (25%) 1. Work alongside the IRB specialist; provides back-up as needed with high demand and during absences. Communicates closely with study team and IRB specialist on triaging regulatory priorities in terms of study start-up, study updates, protocol amendments, etc. 2. Facilitates and manages e-consent set-up and Florence e-regulatory binder processes 3. May assist with continuing reviews for active studies, update IRB as needed for AEs, UPIRTSOs, etc. 4. Maintains up-to-date knowledge of HIPAA, regulatory guidance and institutional requirements (NIH, FDA, UMN Research Requirements, Fairview Requirements, Health and Human services) 5. Oversee the maintenance of central regulatory files and staff credentials. 6. Manages study archival at end of project. 7. Follow Good Clinical Practice Grant/Budget Preparation & Oversight (30%) 1. May develop or assist with budget development and obtaining pricing estimates 2. Tracks and monitor expenses and study budget. 3. Monitors trial budgets with the assigned coordinator to assure appropriate and adequate ongoing resourcing. 4. Oversees Material transfer agreements and Confidentiality Agreements 5. Ensure deadlines, schedules and budgets are met while keeping in compliance with local regulations and GCP. Research Unit Liaison (external sponsors/monitors, MDs, IRB, and Department) (10%) 1. Meets directly with principal investigator to facilitate problem solving and redesign of study/project, when necessary. 2. Attend meetings with Fairview departments on billing and pricing issues and supply contract 3. Identify and work to implement resources needed Technical Knowledge and Skills: 1. Knowledge of principles and practices of project management. 2. Experience with managing clinical trials. 3. Ability to work with investigators of all xperience levels. 4. Knowledge of regulations, policies and procedures at the University of Minnesota in clinical research 5. Skill in the effective use of computer systems and software 6. Skill in ensuring the accomplishment of team or work unit goals, objectives and activities. Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery. The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations. Qualifications Required Qualifications: BA/BS degree and at least five years of experience, or an advanced degree and at least three years of experience, or a combination of education and experience totaling at least 9 years. 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 counseling at no cost Please visit the 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... 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.