HonorHealth Clinical Trials Operations Specialist in SCOTTSDALE, Arizona
HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses six acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation and community services with approximately 12,300 employees, 3,700 affiliated physicians and 3,100 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth’s mission is to improve the health and well-being of those we serve.
This specialist position will be primarily responsible for research study budget development & negotiations as well as study startup & maintenance coordination.
Job SummaryThis position is responsible for operationalizing clinical trials and associated amendments throughout the lifecycle of the study.
The position's competencies include operations, Medicare coverage analysis/budgeting, contracting and CTMS.
The successful Clinical Trial Operations Specialist will lead 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, and participates in activities that will help determine study feasibility. The tasks the Clinical Trial Operations specialist must be able perform are to (i) problem solve at a strategic level (ii) careful planning to achieve accurate and timely results, (iii) positively influencing others to reach objectives and milestones, and (iv) the ability to work independently with minimal supervision.
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 the 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 study start-up and maintenance. (E.g. contract(s), supplies, departmental, contractors/vendors). Coordinate resources to ensure that they are properly allocated 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).
Develop comprehensive project plans to be shared with program stakeholders. Set deadlines, assign responsibilities, monitor and summarize progress of project. Prepare reports for 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 synch.
- 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 lifecycle of research department agreements. Initiate, coordinate, implement and manage the clinical trial research contracting process from submission request through contract execution.
Review, analyze, and negotiate contract terms in accordance with institutional guidelines for clinical research projects. Determine when to escalate concerns for business or legal decisions.
Ability to prioritize objectives across multiple business units.
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.
- Responsible for the timely and accurate delivery of study treatment plan builds in the CTMS. This includes accurate transference of the 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 clinic need. This includes tracking study build progress using a work flow management system.
EducationBachelor's Degree Scientific, Business, Medical, Legal or Financial discipline RequiredExperience3 years Progressively responsible clinical research operations experience, including lead experience. Required