Clinical Research Coordinator 4, Post-Award Supervisor

Job Overview Clinical Research Coordinator-4. Plan, organize, lead, and perform comprehensive and advanced level clinical research duties for multiple and/or complex clinical trials. A CRC-4 has the ability to directly impact the overall efficiency, productivity, and success of each clinical trial they coordinate. The CRC in this role is able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective Department or Division to meet the needs of a given study. The CRC in this role may manage or support a research team of CRCs. Responsibilities Evenly divided between primary study coordination and post-award activities for the orthopedic department, working with the pre-award supervisor to ensure all aspects of the clinical trial lifecycle are supervised. Manage multiple Principal Investigator relationships with internal and external research stakeholders. Provide guidance and assistance to Principal Investigators for grant submissions, budget development & negotiation, study feasibility, and research compliance oversight to ensure full compliance with local, state, and federal policies and procedures. Emphasize managing the active study budgets, tracking sponsor invoices and payments, and all post-approval financial aspects. Serve as the primary liaison with the Sponsor for assigned studies. Assist Principal Investigator in developing clinical trial protocols and submitting required documentation to the Institutional Review Board, the University, federal regulators, and industry or government sponsors. Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity. Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval. Participate in planning and analysis of research portfolios, in conjunction with department management, leadership, and Principal Investigators. Oversee the financial management of multiple clinical research projects, including budget development, billing reconciliation, and quarterly review of all Principal Investigator accounts. Oversee the CRCs to ensure enrollment progress and milestone completion is timely. Work with Clinical Trials leadership to manage a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities that include hiring, scheduling, workload management, compensation, rewards, professional development, and performance management. Coordinate clinical research education, training, and/or orientation for new Faculty, Fellows, Residents, or medical students. Provide guidance and training to research coordinators and departmental staff on post-award financial management, sponsor invoicing, and regulatory requirements. Develop administrative and financial recommendations for department management and Principal Investigators for research portfolio review. Oversee Clockify for clinical research coordinators and improve time each week based on departmental guidelines. Compile data and documents during internal and external audits and be ultimately responsible for quality of submissions. Participate in at least one research-related working group at the institutional level, or lead a process improvement initiative at a department or division level. Conduct research data analysis and literature searches. Co-author scientific papers, publications, or presentations. If unfunded or under-funded, identify the funds needed and assist investigators in submitting proposals to the research committee for approval; once approved and funding source identified, work with research administrators to load info in Clockify. Identify opportunities to streamline study start-up processes and reduce activation timelines. Track key start-up metrics including time to budget finalization and study activation. In addition to the above job responsibilities, other duties may be assigned. Minimum Requirements CRC 4 non-licensed Education: Bachelor's Degree Required or equivalent combination of experience, education, and certifications. Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master’s or other advanced degree may substitute for one year of clinical research experience. Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. CRC 4 licensed Education: Bachelor's Degree Required or equivalent combination of experience, education, and certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse. Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master’s or other advanced degree may substitute for one year of clinical research experience. Licensure: Licensed to Practice in Clinical Profession such as Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy. Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Preferred Qualifications Master’s degree in Public Health (MPH), Healthcare Administration (MHA), Business Administration (MBA), or related field. Experience with Clinical Trial Management Systems (CTMS) such as OnCore. Experience working with contract research organizations (CROs) and industry sponsors. Clinical trial budget development and negotiation. Study start-up coordination and timeline management. Financial feasibility analysis for clinical trials. Knowledge of clinical trial billing compliance and coverage analysis. Stakeholder communication and negotiation skills. Project management and organizational skills. Attention to detail and regulatory awareness. Physical Demands and Benefits This is primarily a sedentary job involving extensive use of desktop computers. The job occasionally requires traveling some distance to attend meetings and programs. This position operates within a collaborative academic medical center research environment supporting clinical and translational research programs. Salary will be commensurate with education and experience. This is an exempt-level, benefited position. This is a restricted position, which is dependent on funding and is contingent upon funding availability. This position is based in Charlottesville, VA, and is eligible for a hybrid schedule, in accordance with UVA’s remote work guidelines. Equal Opportunity Employer The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA’s commitment to non-discrimination and equal opportunity employment. #J-18808-Ljbffr