Clinical Research Coordinator (Research Professional 3)- Dept. of Orthopedic Surgery

About the Job Study Participant Recruitment and Management - 60% Enroll appropriate participants into clinical trials with regards to the established protocol, Good Clinical Practice, and University of Minnesota  and Clinical Partner policies. Obtain consent from participants. Coordinate participant study visits and ensure complete source documentation. Complete sponsor case report forms (CRFs), coordinate monitoring visits and arrange for lab visits and imaging if necessary. Complete and manage adverse event (AE), serious adverse event (SAE) and deviation logs per department/sponsor requirements. Responsible for knowing protocol details, ensuring that protocol is followed, documenting study activities appropriately, and resolving issues that arise during day-to-day implementation of studies. Study Regulatory Management - 30% Prepare and complete IRB (Institutional Review Board) applications, informed consent documents, and data collection forms as well as completing continuing review reports and regulatory reports in a timely manner. Prepare and complete other regulatory documents, including delegation of authority logs, financial disclosure forms, FDA forms (1572s, etc.) Manage and maintain a regulatory/essential documents binder for each study from initial submission to study closure. Assure compliance with all regulations and sponsor stipulations as necessary. Manage and maintain accurate list and status of research activities within area of responsibility. Protocol Development, Implementation, and Execution- 5% Support protocol development for research initiatives. Write and edit research and technical materials including IRB applications, protocols, consent forms, grant applications, research manuscripts, presentations, abstracts, website content, and user guides. Operationalize research protocols for multiple projects, including social/behavioral NIH-funded trials and industry sponsored clinical trials. Independent Projects- 5% Mentor and train junior research staff. Manage additional workload and trials during staffing changes. Provide process improvement and CRC perspective for work flow improvement. Contribute towards departmental goals and strategy. Complete special projects as assigned Qualifications All required qualifications must be documented on application materials Required Qualifications: Bachelor of Science plus at least 4 years of experience, or advanced degree and 2 years of experience, or a combination of related education and work experience to equal 8 years. Clinical trial experience. Experience with IRB submissions and IRB reporting requirements Experience recruiting, consenting and enrolling patients in clinical research studies. Experience with tracking patient enrollment, completing source documents and case report forms. Demonstrated excellence in customer service and patient community skills. Experience interacting with clinic staff and patients to ensure complete and accurate collection of patient-reported outcome measures. Strong interpersonal and communication skills, and ability to work with a diverse community and a diverse set of stakeholders including researchers, clinicians, support staff and patients. Ability to work independently and prioritize tasks. Preferred Qualifications: Strong working knowledge and experience navigating EPIC Experience setting up projects and using OnCore CTMS Familiarity with ETHOS Academic clinical research experience Familiarity with Orthopedics, and willingness to learn. Skilled in the effective, efficient and safe use of equipment. Strongly preferred ACRP or SOCRA certification (CCRC, CCRP, or CCRA) About the Department To learn more about the Department of Orthopedic Surgery: https://med.umn.edu/ortho  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 Scholarship 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 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 [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:  http://diversity.umn.edu. 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. Please note: All employees at the University of Minnesota are required to comply with the University’s Administrative Policy: COVID-19 Vaccination and Safety Protocol by either providing proof of being fully vaccinated on their first day of employment, or complete a request for an exemption for medical exemption or religious reasons. To learn more please visit: https://safe-campus.umn.edu/return-campus/get-the-vax 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.