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Job ID359676 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P2 Employee ClassCivil Service About the Job JOB SUMMARY The Clinical Research Coordinator II is responsible for providing technical expertise and overall management of clinical research data collection, study documentation, protocol-required procedure execution, and collaboration with PI and study team to ensure consistent and accurate implementation of the protocol. The incumbent will be expected to follow Good Clinical Practice (GCP) and all organization policies and procedures for patient safety and data integrity, including but not limited to the Institutional Review Board (IRB), Food & Drug Administration (FDA), Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines. SPECIFIC RESPONSIBILITIES Trial Management / Study Coordination (60%) * Interprets protocols and creates source documents needed for clinical research study * Identifies and reports protocol deviations within the required timeline in accordance with institutional requirements * Ensures protocol adherence by communicating and ensuring study parameters are executed according to protocol * Oversees visits with outside sponsors, including site initiation visits, interim monitoring visits and closeout visits * Collaborates with PI and study team to enroll study participants, execute study-required procedures, and maintain accurate source documentation * Maintains a processing and tracking system for protocol-required biospecimens, data, and procedures * Works as a member of the study team with positive and timely written and verbal communication, including sharing information up, down, and laterally * Troubleshoots problems in the development and implementation of protocol procedures * Coordinates with Investigational Drug Services (IDS), BioNet, clinical staff, and other bodies across campus to deliver drug, collect biospecimens, and execute the study visits according to protocol Data Management (40%) * Serves as primary contact for the collection and completion of required study documentation * Develops and maintains study documentation to ensure audit-proof compliance * Abstracts data from medical record to ensure accurate and complete source documentation * Manages electronic data capture systems, including but not limited to building the case report forms, responding to queries, and meeting data lock deadlines * Demonstrates proficiency with Common Terminology Criteria for Adverse Events (CTCAE), medical terminology, critical lab values, and other disease-specific diagnostic criteria Qualifications All required qualifications must be included in the application materials REQUIRED QUALIFICATIONS * BA/BS with at least 2 years of experience or 6 years of relevant education & healthcare or research experience * Excellent attention to detail and organizational skills * Ability to work independently, as part of a team, and with changing priorities * Computer proficiency in a PC environment including Microsoft Office products * Ability to sit for extended periods of time PREFERRED QUALIFICATIONS * Oncology research experience in an academic setting * Experience with patient contact / care * Experience abstracting clinical data and familiarity with medical terminology * Clinical Research Coordinator certification * Experience with Epic, Oncore, or equivalent medical record / Clinical Trial Management Systems About the Department The Masonic Cancer Center creates a collaborative research environment focused on the causes, prevention, detection, and treatment of cancer applying that knowledge to improve quality of life for patients and survivors and sharing its discoveries with other scientists, students, professionals, and the community. Founded in 1991, MCC became a National Cancer Institute-designated comprehensive cancer center in 1998 and is now one of only 50 institutions in the United States to hold this designation, which is awarded only to institutions that make ongoing, significant advances in cancer research, treatment, and education. Many people choose to work at the University of Minnesota MCC because they believe in our mission and are excited by our vision for the future. We have a reputation as a great place to work with excellent leadership and a strong community that values diversity. The University of Minnesota provides a very competitive benefits package and access to many resources and professional development opportunities. 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 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 with free or reduced rates in the Twin Cities metro area 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 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... 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.