Overview Looking to be part of something more meaningful? At HonorHealth, you'll be part of a team, creating a multi-dimensional care experience for our patients. You'll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact. HonorHealth offers a diverse benefits portfolio for our full-time and part-time team members designed to help you and your family live your best lives. Visit honorhealth.com/benefits to learn more. Join us. Let's go beyond expectations and transform healthcare together. HonorHealth is one of Arizona's largest nonprofit healthcare systems, serving a population of five million people in the greater Phoenix metropolitan area. The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more. With nearly 17,000 team members, 3,700 affiliated providers and close to 2,000 volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional healthcare system to improve the health and well-being of communities across Arizona. Learn more at HonorHealth.com. Responsibilities Job Summary This position is responsible for operationalizing clinical trials and associated amendments throughout the lifecycle of the study. The position's competencies include project management, clinical trial operations, coding/billing compliance, Medicare coverage analysis/budgeting, contracting, Clinical Trial Management Systems (CTMS), and familiarity with basic finance and accounting principles. The successful Clinical Trial Operations Specialist will support Research Program Managers and coordinate the activities of a multidisciplinary team required for study start up and maintenance. This position will serve as a clinical research operations liaison with Research Administration, and the research staff. The tasks the Clinical Trial Operations Specialist must be able perform are to (i) problem solve at an operational level and determine escalation needs (ii) triaging escalations from junior staff, (iii) careful planning and coordination of operations to achieve accurate and timely results, (iv) positively influencing others to reach objectives and milestones, and (v) the ability to work independently with minimal supervision while cultivating knowledge, skills, and experiences for Sr Specialist role This position takes responsibility to plan, resource, communicate, and manage all of the tasks required to operationalize clinical research. This position reports to the Operations Manager, and works closely with Principal Investigators, Clinical Program Leads, Regulatory, Finance, Clinical Trials Personnel, Legal Counsel, and Research Administration. Essential Functions Develop and maintain positive working relationships with physicians, industry sponsors, contract research organizations, attorneys, hospital departments, other internal staff and external entities in order to drive project execution within projected timelines. Correctly identifies the @types of resources that need to be in place for study start-up and maintenance. (E.g. contract(s), supplies, departmental, contractors/vendors). Coordinate resources and ensure proper allocation so that all projects are delivered on-time. Develop and maintain a detailed internal budget for studies in accordance with the protocol, the Medicare coverage analysis, and internal pricing guidance. Review and update the external budget to be consistent with the internal budget, ensuring fair market value ranges and negotiate with sponsors and vendors accordingly. Accurately determine and record the vendors for each protocol required procedure. Ensure each vendor is being paid according to their contract (if external) or policy (if internal). Set deadlines, assign responsibilities, monitor and summarize progress of project to produce effective results or outcomes. Prepare reports regarding status of project for stakeholders and management. Ensuring that contracts, budgets, regulatory documents and the systems where they are housed are reconciled and in sync. Ability to interpret the clinical trial protocol and corresponding procedures accurately as they pertain to coding. Regularly researches CMS National Coverage Determinations, Local Coverage Determinations, and non-CMS coverage guidance. Effectively uses the Medicare Clinical Trial Policy to formulate reasonable assumptions for coverage based on trial @types and their respective qualifying statuses. Formulates strong coverage guidance in accordance with Medicare Clinical Trials Policy and in line with the HonorHealth Policy. Facilitates consistency between the coverage analysis, budget, and any system that represents a protocol's treatment schedule or calendar, including but not limited to Clinical Trials Management System and the Electronic Medical Record. Responsible for the life cycle of research department agreements. Initiate, coordinate, implement and manage the clinical trial research contracting process from submission request through contract execution. Maintains the contract over the study life cycle to support amendments and modifications reflecting changes to study protocol. Review, analyze, and negotiate contract terms in accordance with institutional guidelines for clinical research projects. Achieves competency in recognizing variances to general guidance and demonstrates proficiency in appropriately escalating and resolution in collaboration with management teams. Determine when to escalate concerns for business or legal decisions. Ability to prioritize objectives across multiple business units. Identify new relationships within HonorHealth to optimize current business practices. Responsible for the timely and accurate delivery of study billing plan builds in the CTMS. This includes accurate transference of billing logic and financials into the CTMS. Responsible for coordinating and driving internal timelines for both new study builds and amendments so that the CTMS is available prior to study activation. This includes tracking study build progress using a workflow management syst. Education Master's Degree Business, Research, or Legal discipline - Preferred Bachelor's Degree or 4 years' work related experience Scientific, Business, Medical, Legal or Financial discipline - RequiredExperience 2 years Experience with contracts and reimbursement rules and regulations governing standard of care and research billing. - Preferred 2 years Clinical Trail Management System (CTMS) experience - Preferred 3 years Financial experience including contract negotiation and budget development and negotiation experience. - Preferred 5 years Progressively responsible clinical research operations experience, including lead experience. - RequiredLicenses and Certifications
