Overview
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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 15,000 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. Ideal candidates for this role will have experience with negotiation and relationship management experience, and revenue cycle.
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 operations, coding/billing compliance, Medicare coverage analysis/budgeting, contracting, Clinical Trial Management Systems, and familiarity with basic finance and accounting principles.
The successful Associate Clinical Trials Operations Specialist will support business activities of the Honor Health Research Institute's Clinical Trials Office (CTO)through coordination of the activities of a multidisciplinary team required for study start up and maintenance. This position will serve in a support role for pipeline, primary start up; and project modification operations within the CTO. This role will interface closely with with Research Administration, the research staff, and lead CTO staff to facilitate task management ensuring efficient pipeline processing, study starts, and turnaround times on study modifications requiring changes in contract or budget terms. The tasks the Associate Clinical Trial Operations Specialist must be able perform are to (i) problem solve at a process level (ii) careful planning and coordination of delegated tasks within scope of the role to ensure accurate and timely results, (iii) positively influencing others to reach objectives and milestones, and (iv) the ability to work independently with minimal supervision while cultivating knowledge, skills, and experiences for the Clinical Trial Operations Specialist role
This position takes responsibility for supporting, the planning, communication, and management of key documents required to maintain clinical research over the study life cycle. 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.
- 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 completion of delegated tasks supporting study start-up and maintenance(e.g. contract(s), coverage analysis, , departmental, contractors/vendors). Coordinate and escalate deficiencies to manager and appropriate stakeholders to secure resources and ensure proper allocation so that all projects are delivered on-time.
Develop and maintain processes to ensure the Medicare coverage analysis, CTA, budget, CTMS build, and protocol versions align over study life cycle.
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).
Contributes to the development of comprehensive project plans to be shared with program stakeholders. Works with stakeholders to ensure project goals and objectives are being met. When appropriate, may set deadlines, assign responsibilities, monitor and summarize progress of project. Prepare reports regarding status of project for stakeholders and management.
Ensuring that contracts, budgets, regulatory documents and the systems where they are housed are aligned and updated to reflect most current version of the protocol.
- 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 Policies and business standards.
Facilitates consistency between the coverage analysis, budget, and any IT system that represents a protocol's treatment schedule or calendar, including but not limited to Clinical Trials Management System and the Electronic Medical Record.
- Engages maintenance tasks throughout the life cycle of research department agreements. Works closely with lead Clinical Trials Office staff to 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. Determine when to escalate concerns for manager or operational stakeholder support.
Ability to prioritize objectives across multiple business units.
- Responsible for the timely and accurate delivery of study billing plan builds in 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.
Qualifications
Education
Associate's Degree or 2 years' work related experience Required
Experience
2 years Relevant work experience and familiarity with operational roles, functions, and/or processes. Required
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HonorHealth
Nov 13, 2024