Clinical Trials Operations Specialist - HonorHealth Research Institute - Up to $10k Transition Incentive Bonus

Overview

This 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.

• Develops and maintains 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.
• Develops and maintains a detailed internal budget for studies in accordance with the protocol, the Medicare coverage analysis, and internal pricing guidance. Reviews and updates the external budget to be consistent with the internal budget, ensuring fair market value ranges and negotiate with sponsors and vendors accordingly.
• Accurately determines and records the vendors for each protocol required procedure. Ensures each vendor is being paid according to their contract (if external) or policy (if internal).
• Develops comprehensive project plans to be shared with program stakeholders. Sets deadlines, assigns responsibilities, monitors and summarizes progress of project. Prepares reports for regarding status of project for stakeholders and management.
• Ensures that contracts, budgets, regulatory documents and the systems where they are housed are reconciled and in synch.
• Interprets 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.
• Manages the lifecycle of research department agreements. Initiates, coordinates, implements and manages the clinical trial research contracting process from submission request through contract execution. 
• Reviews, analyzes, and negotiates contract terms in accordance with institutional guidelines for clinical research projects. Determines when to escalate concerns for business or legal decisions.

Minimum Qualification:

• Bachelor's degree Scientific, Business, Medical, Legal or Financial discipline 
• 3 years progressively responsible clinical research operations experience, including lead experience

Rewards: 

• Up to $10,000 in Transition Incentives 
• Tuition assistance up to $5,250* per year 
• Comprehensive medical, dental and vision insurance with domestic partner coverage 
• 403(b) retirement savings plan that provides immediate vesting and dollar-dollar match up to 4% 
• On-site child and elder care centers 
• Employee assistance program 
• Free parking, discounted bus passes, fitness facilities 

*terms and conditions apply

For more information or to connect with a recruiter, email resume to Shelby Stricker: sstricker@honorhealth.com

HonorHealth System Overview: 

• Six acute-care hospitals 
• Three Level I trauma centers 
• 15 Virginia G. Piper Cancer Care Network locations 
• 12,000 employees
• Medical group with 70+ primary, specialty and urgent care locations
• 500+ ongoing clinical trials and studies at the HonorHealth Research Institute 
• System-wide, fully integrated Epic EMR 

Accolades: 

• Five Magnet® recognized hospitals 
• Recognized by Becker’s Hospital Review, 150 Top Places to Work in Healthcare 2019 
• Recognized by Forbes, Best Employers 2017, 2018, 2019 and 2020
• All HonorHealth Medical Centers achieved B or higher rating in the spring 2019 The Leapfrog Hospital Safety Grades 

Learn more and apply online: Jobs.HonorHealth.com

Phoenix and Scottsdale are known for high-end resorts, golf courses, vibrant nightclubs and professional sports, but the city’s biggest attraction may be the sunshine, winter warmth and more than 41,000 acres of mountain parks and desert preserves.

It is the policy of HonorHealth to provide equal opportunity in employment. Selection and employment of applicants will be made on the basis of their qualifications without regard to race, color, religion, creed, national origin, age, disability, sexual orientation, marital status, veteran status or any other legally protected status.

As a community healthcare system, we have a unique responsibility to keep our facilities as safe as possible to protect our patients and team members. With this in mind, we require all new hires to have received the first dose of a COVID-19 vaccine before their start date and be scheduled for their second dose.  New hires who choose to receive the Johnson & Johnson vaccine only need one dose to fulfill this requirement. Reasonable accommodations will be considered.