Research Administrator - Clinical Trials Office - Dartmouth-Hitchcock Health

Provides technical assistance and guidance in the preparation, submission, processing, and management 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 government rules and regulations.

1. Maintain a detailed understanding of Medicare’s Clinical Trial Policy (NCD310.1) and related guidance documents
2. Generate detailed and accurate coverage analysis with budget overlay in a timely manner.
3. Review clinical trial protocols and related regulatory documents in order to prepare a billing plan for all medical procedures and services required in a clinical research project.
4. Review clinical research protocols and determine which procedures are routine, and therefore, billable to Medicare and other third-party payers based on CMS policy and National and Local Coverage Determinations, as well as professional practice guidelines. Extensive independent research to identify applicable practice guideline will be required.
5. Selects patient care charges and connects these charges to the calendar events with appropriate CPT codes to show budget negotiations expected costs
6. Review patient informed consent forms to ensure that the document accurately informs patients which procedures will be billed to their insurance vs. those that will be covered by the study budget, in accordance with the MCA.
7. Ensure consistency of the payment terms in the coverage analysis with the protocol, the informed consent form template, the budget and contract terms.
8. Coordinates with Research Teams to validate the study and patient data in the Registry and to ensure data is consistent with the Dartmouth Billing System and the IRB Database. Manages receipt of and upload all appropriate study related documents. 
9. Completely and effectively document MCA determinations to support the decision-making process.
10. Screen research protocols to determine whether a formal Medicare Coverage Analysis (MCA) is required.
11. Build comprehensive Clinical Trial budgets based on DH pricing methodologies and internal standards

1. Negotiate clinical trial budgets on behalf of DH through email and phone communication with trial sponsor/CRO.
2. Analyze, interpret, and renegotiate when applicable protocol amendments for budgetary impact.
3. Request Department quotes and time estimates for budget preparation
4. Acts as the main study liaison for the CTO and coordinates with the IRB and other internal / external parties to ensure that all required approvals are received prior to study initiation. 
5. Acts as the primary CTO liaison to PI and research staff.
6. Assist Research Teams with navigating their study through the Activation Process
7. Participates in the development of and makes periodic updates to Clinical Trials Business Operations policies and procedures.
8. Trains or assist in training new Clinical Trial Business Office Associates to ensure uniformity and quality of work.

Performs other duties as required or assigned.

• Bachelor’s degree in a related field or the equivalent in education and experience required.
• Four+ years research administration (or experienced research coordinator) work experience preferred.
• Experience in a healthcare or academic research administration setting and knowledge of electronic research administration systems
• Clinical Trials Office: Working knowledge of Clinical Trials Management Systems (CTMS), subject calendar development, Medicare Coverage Analysis, billing/research compliance and/or research budgeting/contracting required.
• Sponsored Projects Office: 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