Apply for Job Job ID362198 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code9742S1 Employee ClassAcad Prof and Admin Add to Favorite Jobs Email this Job About the Job The Process Manager, Translational Research supports the Cancer Research Translational Initiative (CRTI) leadership at the Masonic Cancer Center (MCC) in enhancing translation across Translational Working Groups (TWG) and MCC Programs through process improvement and project management. This role bridges the needs of both therapeutic and non-therapeutic research groups, building robust processes within CRTI to support them effectively. Job Responsibilities: Development of Processes to Support Translational Research - 55% Develop and improve processes for cancer biospecimen management: Create regulatory-compliant processes for cancer biospecimen and data release to MCC investigators and external entities. Enhance biospecimen inventory access for MCC investigators. Develop methods to collect sample/data usage and return on investment metrics from MCC biobanks. Provide support for additional clinical, regulatory and quality related deliverables as assigned. Identify and address gaps within translational processes, assisting CRTI leadership in finding solutions. Identify the translational needs of non-therapeutic research groups and communicate them to CRTI leadership. Serve as the primary contact for non-therapeutic translational cores, addressing resource questions and developing translational processes. Collaborate closely with CRTI team members and MCC stakeholders to develop efficient processes within CRTI. Pre-IND Support - 20% Play an integral role in pre-IND applications, including assembling submission packets and addressing FDA questions/comments in line with regulatory guidelines. Identify the relevant FDA office for the IND product and assist the study team in completing the briefing packet. Assemble and submit the pre-IND application in a professional, best-practice format. Interpret FDA comments and relay information to protocol writers for the IND application and subsequent amendments. Research Navigator - 15% Manage and refine the process for requesting services for both therapeutic and non-therapeutic efforts, connecting investigators to MCC/UMN resources and services. Collaborate with MCC Shared-Resource leadership and coordinate Shared Resource Internal Advisory Committee meetings. Administrative - 10% Work with CRTI leadership to track and manage translational activities across TWGs and MCC Programs. Organize CRTI-sponsored events such as annual faculty training, symposiums, and retreats. Track CRTI departmental metrics (DSG, DBUC, Industrial Partnerships, CRTI-management work). Collaborate with CRTI leadership to address any opportunities, problems, or gaps in projects that may arise. Perform other miscellaneous duties as assigned. Qualifications Required Qualifications: Requires BA/BS with at least 6 years of experience or advanced degree with 4 years of experience. Proven excellence in oral and written communication skills. Excellent customer service skills and coordination experience. Strong organizational skills. Extensive experience with Microsoft Office. Ability to prioritize and multitask, managing multiple projects simultaneously and completing tasks accurately and on time. Capability to work independently, using creativity and initiative to overcome obstacles. Experience collaborating with all levels of an organization; must be a team player. Preferred Qualifications: Advanced degree (preferred) or Master's degree with an emphasis on clinical sciences. Experience in an academic or clinical research setting. Regulatory/GCP experience. Experience with IND/ITP applications to the FDA. Experience with report writing. Demonstrated problem-solving abilities. Flexibility in a fast-changing environment. About the Department The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive C ncer Center dedicated to cancer research, education, and patient care for the citizens of Minnesota and the surrounding region. Since the time of the first award in 1997, there has been consistent growth of the membership and research base, enabling our center to further advance our knowledge and enhance care for our catchment area. We are driven to be the choice academic healthcare environment for patients, clinicians, scientists and students who seek exceptional, compassionate, precision cancer therapy; innovative clinical trials and prevention programs; cutting-edge research opportunities; and outstanding advanced education. 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 Regents Tuition Benefit Program 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) opportunity Financial counseling services Employee Assistance Program with eight sessions of counseling at no cost Employee Transit Pass with free or reduced rates in the Twin Cities metro area Please 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 Employment 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... 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.