Pre Award Specialist

About the role

The Pre Award Specialist provides direct support to Principal Investigators, the Network Office of Research and Innovation (NORI) leadership, and study teams in preparing and facilitating clinical study feasibility reviews, Medicare Coverage Analyses, and budget and contract negotiations. This role ensures compliance with federal, state, and sponsor regulations.

Key responsibilities

• Facilitate study feasibility reviews, including financial and operational assessments.
• Lead feasibility meetings with study teams, Principal Investigators, and NORI leadership.
• Prepare Medicare Coverage Analyses to ensure appropriate billing of research-related charges.
• Develop and negotiate study budgets and contracts, covering personnel and procedure costs.
• Maintain study records in the Clinical Trials Management System (CTMS) and process protocol amendments.
• Support the pre‑award process for grant‑funded research projects as needed.

Required profile

• Bachelor’s degree in Nursing, Accounting, Finance or related field.
• At least 2 years of experience analyzing, drafting, and negotiating complex budgets and agreements, or 2 years in clinical research.
• Knowledge of CMS national coverage determinations, FDA Good Clinical Practices, and relevant federal regulations (e.g., 21 CFR Parts 11, 50, 54, 56, 312, 812).
• Ability to lift and carry up to 25 lb and perform typical office tasks.

Required skills

• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Experience using a Clinical Trials Management System (CTMS).