Job ID358791 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P2 Employee ClassCivil Service About the Job The primary purpose of this position is to support clinical research projects in a variety of pediatric specialties according to regulatory requirements, institutional guidelines, and sponsor expectations. The Clinical Research Coordinator facilitates the conduct of research according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, coordinating the enrollment of eligible patients, regulatory management, extracting and reporting quality patient data and tissue samples, and responding to data queries. This position reports to the Research Project Manager, but is accountable to the program leaders, the physician-investigators, and members of the clinical research team. (75%) Clinical Research Coordination: Manage all study-related activities, including participant recruitment, enrollment, study visits, data and specimens, and sponsor visits for assigned research projects Provide back-up support and research coordination across specialties as needed Assist the study team in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and timely acquisition of research tissue Support the study team to ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts Assist the Research Nurse in ensuring the timely review and reporting of adverse reactions and severe adverse events Contribute to the production of research publications or presentations of research data (15%) Regulatory Management: Prepare regulatory submissions in collaboration with the PI, including annual reviews, protocol amendments, and consent form modifications Support the maintenance of essential regulatory documents (including DoA logs) and regulatory binders for assigned research projects Responsible for regulatory entries in the Clinical Trials Management System (OnCore) Prepare for and participate in site initiation visits, monitoring visits, program audits, etc. Report Unanticipated Problems according to University policy (10%) Education: Serve as a mentor for CRC-1's as requested by the Education Lead and Project Manager Educate others of our regulatory and research obligations in relation to our clinical research activities Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care Qualifications All required qualifications must be documented on application materials Required Qualifications: BA/BS in a scientific or health related field and two years of experience in a medical setting, OR a combination of education and experience in clinical research to equal to 6 years Ability to work flexible work hours, including evening and weekends 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 Preferred Qualifications: Excellent written, verbal and interpersonal skills Specimen management skills, or willingness to learn (including processing human samples and shipping per regulations) Detail-oriented with exceptional organizational, planning and problem-solving skills Ability to work independently, as a part of a team and with changing priorities Demonstrated ability to maintain deadlines and prioritize assignments Knowledge of clinical research Experience with Epic or other electronic medical record system Experience with patient care / contact Experience with computerized data management Benefits Working at the University At the Universit 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 [email protected] or call (612) 624-UOHR (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: 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. At the University of Minnesota, we are... 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.