Remote CRA: Pre-Randomization Review & Site Engagement

Our Boston area biotech client is seeking an experienced Clinical Research Associate (CRA) to support pre‑randomization review activities across global study sites. This role focuses on verifying seizure count calculations and ensuring appropriate source documentation is in place in alignment with protocol requirements and GCP. The position is designed to provide timely, targeted review and site engagement without mandating specific source tools or workflows. Work Model • On‑call, as‑needed support aligned to enrollment timelines • Regionally aligned (e.g., US, EU, Japan) to ensure time zone responsiveness • Primarily remote, with limited site interaction as needed Key Responsibilities • Conduct targeted review of seizure count calculations prior to patient randomization • Engage directly with site staff to clarify documentation concerns and request additional supporting information when needed • Provide clear, timely feedback to the study team and escalate issues appropriately • Apply clinical judgment and critical thinking to ensure eligibility verification and documentation accuracy Qualifications • 5+ years of CRA experience in clinical trials (neurology or epilepsy experience preferred) • Strong understanding of GCP, source documentation standards, and eligibility verification processes • Experience with remote monitoring and/or centralized review models • Demonstrated ability to work independently and manage rapid‑turnaround requests • Excellent communication skills and experience engaging investigational sites • Ability to assess data quality and documentation completeness with sound clinical judgment