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University of Minnesota - 15th Ave Regulatory Specialist 1 in Minneapolis, Minnesota

Job ID344839 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P2 Employee ClassCivil Service About the Job This position is responsible for providing regulatory guidance and regulatory management of clinical research protocol documents and activity from initial submission through study closure for clinical trials conducted in the Clinical Trials Office (CTO) of the Masonic Cancer Center. Incumbent at this level is an experienced professional competent to work at a high technical level. Responsibilities/duties: Regulatory Management of Clinical Studies (100%) Provides regulatory guidance and direction to all members of the research team in order to ensure compliance with federal regulations, good clinical practice as well as sponsor, University and CTO policies. Serves as primary contact for purposes of collection and completion of required regulatory documentation. In collaboration with the Principal Investigator, interprets protocols and creates consent documents needed for clinical research study. Prepares regulatory approval applications, respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained. Track all regulatory review submissions and approvals to ensure deadlines are met. Maintain regulatory documentation to ensure compliance and audit-ready at any given time. Coordinates the processing of outside safety reports and local serious adverse events. Reports unanticipated problems involving risk to subjects or others (UPIRTSO) within the required timeline. In collaboration with research team, provides support and oversees visits with outside sponsors, which may include prequalification, site initiation, interim visits and closeout visits. Serves as the regulatory subject matter expert through all phases of a clinical study. Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications. Qualifications All required qualifications must be documented on application materials. REQUIRED Qualifications : Bachelor\'s degree in health, public health, biomedical disciplines plus two years of work experience in research; or a combination of related education and work experience in research totaling six years. Experience with regulations governing research activity (such as but not limited to GCPs, FDA regulations and ICH guidelines). Experience developing and working complicated project schedules. Computer proficiency in a PC environment including Microsoft Office products. PREFERRED Qualifications: Clinical Research Coordination certification. Experience in oncology clinical research setting. Previous professional experience on a clinical research project team or similar environment. Experience writing and adapting patient consent forms for research studies. Experience in an academic medicine setting. About the Department The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive Cancer 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. 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 acce sing 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-UOHR (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 benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations. 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.