Research Budget Specialist II - Research Administration - Maitland
Location Address: 601 S. Lake Destiny Road, Maitland, FL 32751
Full Time, Days
You Will Be Responsible For:
Reads and reviews clinical trial/study protocols, informed consent forms, and other related documents and develops a budget for negotiation purposes.
Negotiates budgets and contract terms with sponsors, and prepares necessary supporting documents as requested by the sponsor.
In coordination with the research team, ensures coverage analysis is performed accurately and in compliance with all applicable regulations and institutional requirements
Keeps abreast of Center for Medicare and Medicaid Services (CMS), National Coverage
Determination (NCD) for Routine Costs in Clinical Trials (310.1), and other regulatory updates to best inform the coverage analysis process
Translates study budget into contract language and budget negotiations as needed
Advises PIs, researchers, and departmental staff in the compliant clinical regulatory and fiscal conduct of projects
Provides assistance in proper interpretation of research award terms and conditions, applicable regulations, and institutional policies and procedures to ensure compliance (e.g. Stark Law, Anti-Kickback, Safe Harbor, etc.)
In collaboration with the research team, and other stakeholders, makes recommendations on to institutional policies and procedures to ensure compliance with all applicable regulations regarding research billing compliance
Assists with special projects in research administration processes as assigned
What You Will Need:
Associate degree in business administration, finance, healthcare, or research-related field
One to two years of experience in clinical research (industry/pharmaceutical and/or federal grants), billing compliance, research contract management, research administration, or budget development.
Proficient in Microsoft Office Suite (Word, Excel, and Outlook)
Proficient in understanding clinical trial protocols and budgets
Attention to detail, organized, strong analytical skills, and self-starter
Key focus on customer service, timely and appropriate communications, able to meet fixed deadlines, and multi-task high volume of complex workload requirements
Certification by a professional research organization such as Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators (SRA), National Council of University Research Administrators (NCURA), Research Administrator's Certification Council (RACC)
Bachelor's degree in nursing, business administration, finance, healthcare, or research-related field
Advanced experience in Excel (V-Lookups, Pivot Tables, Index, etc.)
Experience in clinical research budget development and negotiation
Experience with coverage analysis, research rate setting and interpretation of protocol for budget development and negotiation with industry sponsor
Experience in medical coding or billing
More than three years of experience in clinical research (industry/pharmaceutical and/or federal grants), billing compliance, research contract management, research administration, or budget development
Knowledge of healthcare compliance and federal regulations related to clinical research
Knowledge of AdventHealth policy and procedures regarding clinical research
Knowledge of research regulatory environment
Knowledge of medical terminology
The Research Budget Specialist II, in collaboration with Principle Investigators, researchers, departmental staff, and other ancillary staff is responsible for analyzing and drafting complex clinical trial budgets. Negotiates mutually satisfying terms and conditions for pharmaceutical sponsored, Cooperative group, and institutional clinical trials. Reviews and analyzes clinical trial protocols to determine appropriate cost allocation, resources, and adherence to all applicable regulations and institutional standards. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.
AdventHealth Greater Orlando (formerly Florida Hospital) is one of the largest faith-based health care providers in the United States. For 150 years, we have carried on a tradition of providing whole-person care that not only addresses patients' physical ailments, but also supports their emotional and spiritual well-being. We demonstrate the same level of compassion and care for our employees as well, doing all that we can to help them realize their full potential – both personally and professionally.