Job ID361101 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P3 Employee ClassCivil Service About the Job About the Job: The Department of Medicine is hiring a Senior Clinical Research Coordinator (CRC) to support clinical research projects conducted by the department's Research Operations and Resources (ROAR) Team. The Department of Medicine is one of the top research departments in the United States and represents the largest research faculty group at the University of Minnesota, comprising 11 divisions. The MED ROAR Team supports a high volume of varied research projects across the divisions. The Sr. CRC would be expected to work independently to coordinate clinical research studies according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties are determined by protocol-specific requirements and may include initiating new trials, screening patients for eligibility, coordinating the enrollment of eligible patients, extracting and reporting accurate patient data, managing lab samples/specimens, responding to data queries, overseeing the study progress, and assisting with regulatory tasks. This position is accountable to physician-investigators and members of the clinical research team. This position can support a hybrid work schedule with a minimum of 3 days in-person and will vary depending on the research studies assigned. The position has flexible work hours and could include some early mornings, evenings, and weekends as needed for studies. Job Duties Coordinate Clinical Research Studies & Participants (90%) * Duties are determined by protocol-specific requirements and will include research activity from study startup through closeout and following participants from beginning to completion of the study. * Responsible for the interpretation of, application of, and compliance with Good Clinical Practice (GCP) guidelines, University, Fairview, Clinical Partner, and facility requirements in the conduct, performance, and documentation of clinical research activities. * Complete and maintain necessary training for safety, regulatory, facility access, and data management. * Lead the preparation for and participant in pre-site selection visits, site initiation visits, monitor visits, program audits, etc. by coordinating the visits and schedules, leading facility tours, and ensuring requested information is provided. * Participant in study startup activities following guides and checklists to facilitate the implementation of protocols, assess study related needs, create source documentation, visit checklists, and logs or other documents as required. * Complete and maintain accurate study records, including essential, source, and regulatory documents, logs, and supplies inventories. * Monitor supplies and investigational product inventories, ordering new additional as well as disposing of expired/unused items when needed, establish storage location and maintain organization of items. * Lead the evaluation of a study protocol to ensure the appropriate personnel, such as investigators, clinical nurses, lab staff are available to perform research activities, making recommendations for clinical research staffing needs. * Facilitate the collaboration with clinical providers and other departments to ensure smooth implementation and operation of the research protocol. * Demonstrate effective and efficient communication with study sponsors, monitors, external and internal partners. * Lead the training of study staff, clinical, and lab partners on study protocols. This includes, but is not limited to: assisting in creation of training materials, delivering education to research and clinical staff, and continually re-educating during the active phase of the active phase of the research project * Conscientiously conduct research study activities to protect and promote participant safety, communicating clearly and promptly about any potential concer s * Problem solve, delegate direct and indirect research activities to appropriate personnel based on needs, condition, and potential for risk/harm, complexity of the activity and predictability of the outcome * Identify potential risks and take steps to promote participant safety, determine priority problems and implement plans to address. * Comply with all adverse-event (AE), serious adverse event (SAE) and protocol deviation reporting regulations, ensuring appropriate documentation. * Coordinate monitoring visits, ensuring access to internal systems as needed, documents and materials are available for review, meetings are scheduled with the PI, pharmacy, etc. as needed, monitor questions are answered and all followup action is completed and disseminated to relevant stakeholders. * Manage research participant activities, which includes recruiting potential participants, assessing eligibility, obtaining informed consent, perform research procedures for the collection of accurate and complete research data at study visits, ensuring that all needed elements are completed per protocol and correctly and completely documented, collect and ship specimens, complete any after visit actions, including accurate data entry, schedule required visits and tests, ensuring prompt followup for any adverse events. * Duties may change or other duties may be assigned to meet the needs of the ROAR study portfolio. Research Study Operations & Regulatory Management (10%): * With the guidance of a regulatory specialist, prepare study documents and applications for IRB submission, obtain regulatory (IRB and ancillary review) approval, submit study modifications, continuing reviews, RNIs, and ensure studies retain regulatory approvals. * Participate in quality control and internal monitoring activities * Develop study implementation plans relating to patient recruitment, enrollment, study protocol procedures, participant retention, and other processes as needed * Track study progress and ensure target milestones are met as applicable throughout the life cycle of the study. * Utilize institutional research knowledge to share expertise, information, and advise investigators on required university policies and/or federal regulations related to clinical research to advance research aims. * Act as a liaison between Investigators, University departments, outside sponsors, clinical partners, collaborators, and affiliates. Educating University faculty and staff on regulatory and research processes. * Aid in the development of standard operating procedures, guides, or workflows for research processes * Delegate research activities to appropriate personnel based on needs, condition, and potential for risk/harm, complexity of the activity and predictability of the outcome. * Contribute to the education of other research coordinators through training and guiding new staff, participating in mentoring opportunities, and engagement with the University clinical research community Qualifications Required Qualifications: -Bachelor's degree in a health related field plus 4 years of work experience in research; or advance degree plus 2 years of work... 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.