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GENERAL OVERVIEW:
This role possesses an advanced and strategic understanding of executing clinical trial agreements and negotiating trial budgets. Proficient use of Clinical Trial Management Systems and Medicare Coverage Analysis to maintain billing compliance and financial integrity. Serves as the functional lead, responsible for mentoring and training the Office of Sponsored (OSR) Research staff. May help manage the team of analysts, including performance reviews and professional development. Initiates and contributes to policy and procedure development. Including developing and offering enhancements to procedures and business forms. Proactively identifies opportunities for strategic process improvement within OSR and leads implementation. Contributes to other duties as assigned or requested.
ESSENTIAL RESPONSIBILITIES
Efficiently orchestrating the execution of clinical trial agreements, employing a advanced strategic approach to follow institutional guidelines and ensure legal compliance. Proficiently negotiate budgets to ensure comprehensive coverage of all institutional administrative and clinical costs. (30%)
Superior utilization of Clinical Trial Management Systems (CTMS) to streamline workflows, enhance data visibility, and ensure seamless trial execution. Adept at building accurate trial protocols within the CTMS to reflect all associated costs and ensure billing compliance and financial integrity. (20%)
Creating a Medicare Coverage Analyses (MCAs) for each trial, to determine appropriate billing for clinical trial services, interpreting Medicare guidelines and regulations, and maintaining up-to-date knowledge of evolving Medicare policies. Provides guidance and support to ensure accurate billing practices and maximize internal compliance with Medicare guidelines. (20%)
Provides functional leadership, mentoring and training Office of Sponsored Research (OSR) staff to enhance expertise and ensure optimal performance. May oversee or help manage a team of analysts, including performance management and professional development initiatives, fostering a culture of continuous improvement and excellence. (10%)
Initiates and contributes to policy and procedure development, streamlining workflows through enhancing procedures and business forms. Proactively identifies and leads the implementation of strategic process improvements within OSR. (10%)
Performs other duties as assigned or requested. (10%)
QUALIFICATIONS:
Required
Bachelor’s degree in business, healthcare, finance or related field, OR 6 years of experience within a health care or clinical setting in lieu of bachelor’s degree.
4 years of experience within a health care or clinical setting.
Preferred
Masters’s degree in business, healthcare, finance, or related field
Proven experience in a research-related role such as a Research Clinical Coordinator, Regulatory Specialist, Clinical Research Associate, MCA Analyst, or experience with clinical research contracting, budgeting and negotiations.
Hands-on experience using a Clinical Trials Management System (CTMS) for data management, tracking, and reporting.
Demonstrated ability to interpret and apply complex information from clinical trial protocols to ensure compliance and accurate data collection.
Demonstrated knowledge of federal regulations regarding the protection of human subjects in clinical research.
SKILLS:
Strong computer skills including; using internet browser, Microsoft applications (Word, Excel, Teams)
Knowledge of federal regulations regarding the protection of human subjects in clinical research
Familiarity with medical terminology
Must be able to thrive in a dynamic, fast-paced environment, readily adapt to changing priorities, and work effectively as part of a collaborative team.
Must demonstrate a strong commitment to accuracy and thoroughness, taking ownership of work and ensuring high-quality results.
Must be able to communicate clearly and effectively, both verbally and in writing, with diverse stakeholders, including clinical staff, researchers, and management.
Have the ability to manage multiple tasks, prioritize effectively, and maintain accurate records in a fast-paced environment.
Must possess the ability to identify, analyze, and resolve complex issues related to research protocols and data management, using critical thinking and available resources.
Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.
Compliance Requirement: This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies.
As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company’s Handbook of Privacy Policies and Practices and Information Security Policy.
Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.
Pay Range Minimum:
$31.02Pay Range Maximum:
$48.54Base pay is determined by a variety of factors including a candidate’s qualifications, experience, and expected contributions, as well as internal peer equity, market, and business considerations. The displayed salary range does not reflect any geographic differential Highmark may apply for certain locations based upon comparative markets.
Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law.
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