Senior Research Administrator

Overview

Provides technical assistance and guidance in the preparation, submission, processing, and managements of research proposals. Reviews, negotiates and accepts awards and agreements on behalf of researchers and the institution. Ensures that the administration of research projects is compliant with sponsor terms/conditions, institutional Policies and procedures, and governmental rules.

Responsibilities

Maintain a detailed understanding of Medicare's Clinical Trial Policy (NCD310.1) and related guidance documents

Maintain a detailed understanding of National Coverage Determination and Local Coverage Determinations

Maintain a detailed understanding Medicare Benefit policies for Device studies

Review and interpret Medicare Coverage Analyses and corresponding protocols for budget build and negotiations.

Attend resource meeting with key stakeholder of the study team

Build comprehensive Clinical Trial budgets based on DH pricing methodologies and internal standards.

Negotiate clinical trial budgets on behalf of DH through email and phone communication with trial sponsor/CRO.

Analyze, interpret, and renegotiate when applicable protocol amendments for budgetary impact.

Compile and maintain library of procedural cost for budget development and feasibility, and justifications

Proactively escalating issues or proposing solutions in order to expedite the process

Work closely with the Clinical Trails Research Coverage Analysis Team when not preforming the Coverage Analysis.

Regularly update and work with Clinical Trial Management System OnCore, the Research Database, for each clinical research study, in compliance with DH policies, procedures, and standards.

Qualifications

• Bachelor's degree in a related field or the equivalent in education and experience required.
• Five (5) years research administration work experience required.
• Certification in Research Administration preferred
• Experience in a healthcare or academic research administration setting and knowledge of electronic research administration systems
• Working knowledge of federal regulations relating to grants, contracts, and research compliance a well as non-federal sponsored research
• Ability to work effectively, independently and as a member of a team.
• Ability to exercise judgment, initiative, and discretion and to interact with staff and outside agencies in a professional manner.
• Technological proficiency including email, calendars, databases, and Office suite
• Excellent communication, organization, and customer service skills