Job ID360957 LocationTwin Cities Job FamilySupplemental Employee Full/Part TimePart-Time Regular/TemporaryRegular Job Code0001 Employee ClassCivil Service About the Job The primary purpose of this position is to support clinical trials in the Division of Pediatric Rheumatology, Allergy & Immunology and other pediatric specialties. 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. Responsibilities: (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 tissues 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 Required: Highschool Diploma or Equivalent Combination of education and experience in clinical research to equal to 6 years 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 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: BA/BS in a scientific or health related field and two years of experience in a medical setting OR Combination of education and experience in clinical research to equal to 6 years Knowledge of clinical research Experience with Epic or other electronic medical record system Experience with patient care / contact Experience with computerized data management About the Department At University of Minnesota Department of Pediatrics, our experts, care teams and researchers are illuminating cures that save young lives. Our ground-breaking treatments are improving the lives of children who are ill or injured, and are becoming the standard of care for children across the country and around the world. The Pediatric Clinical Research Services program serves the University's research mission by providing comprehensive research support to faculty investigators conducting medical research in neonates, infants, children, adolescents, and young adults. We accomplish our mission by 1) developing competent professionals specialized in pediatric clinical research, 2) creating effective and efficient pathways for conducting compliant clinical research, and 3) fostering a participant-centric research culture. 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: 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 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,... 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.