Note: The job is a remote job and is open to candidates in USA. Brown University Health is seeking a Sr Research Administrator for Clinical Trials to ensure completion and perform a variety of functions related to the administrative aspects of research clinical trials. The role involves collaboration with Principal Investigators and Study Coordinators to manage the financial and regulatory aspects of clinical trials.
Responsibilities
- Performs a variety of functions related to the administrative, financial and regulatory aspects of research clinical trials
- May lead special projects as needed, utilizing communication and organizational skills in achieving final goals
- In collaboration with Principal Investigators (PIs) and Study Coordinators, reviews and approves administrative, financial and legal aspects of new drug and device clinical trials
- Negotiates contract terms with pharmaceutical sponsors and assists PI/Study Coordinator with study budget negotiations
- Reads and understands applicable sections of study protocol and informed consent, verifies adequate budget, reviews Medicare Coverage Analysis and various internally required documents
- Ensures definition of scope of work and clarity of financial terms and billing provisions, performance requirements and indemnification
- Amends sponsor agreements to meet Hospital standards and requirements
- Interacts with Research Protection Office to ensure compliance with Clinical Trials Office (CTO) and Human Subjects Protection requirements
- Conducts training sessions for investigators and other research staff in the areas of Medicare coverage analysis, EPIC usage, and completion of required documentation
- Reviews internal research billing in EMR (EPIC) and resolves issues with patient billing as they relate to research
- Conducts post-award monitoring of expenses, revenue and activities; meets regularly with Principal Investigators/Study Coordinators to assess financial performance, program sustainability and growth, plans for future studies, personnel issues, and needs for additional assistance and training
Skills
- A Baccalaureate Degree in business, health care, biological sciences or related field
- Must have excellent computer skills in Microsoft Word, Excel, Access and Power Point
- Comfortable in public speaking and training environments
- At least 5 years of progressively more responsible experience in the field of research administration (clinical trials, regulations, requirements), demonstrating knowledge of, and ability to interpret related requirements and regulations and to communicate effectively
- EMR experience preferred
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