Medical Affairs Associate

Job Title: Medical Affairs Associate – Clinical Operations (Remote – West Coast Preferred) Pay Rate: $36.72 / hour Location: Remote (West Coast preferred) Job Type: Full-Time / Contract About the Client Join a world-renowned, pioneering biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapeutics in areas of high unmet medical need. Known for groundbreaking advances in oncology, hematology, and cellular therapy, our client offers a fast-paced, collaborative environment where your contributions directly support critical patient access, clinical trial execution, and life‑saving treatments. Position Summary We are seeking a Medical Affairs Associate to support key operational execution across expanded access programs, out‑of‑specification (OOS) case support, and single‑patient IND processes. In this role, you will collaborate with cross‑functional study teams, manage external vendor performance (CROs), track critical program milestones, and ensure regulatory alignment from study startup through closure. Key Responsibilities Clinical Trial & Program Management: Support clinical trials and treatment‑use programs from startup to closure; coordinate study‑related deliverables, timelines, and documentation. Expanded Access & IND Support: Assist with out‑of‑specification programs, expanded access programs, and single‑patient IND requests, ensuring cross‑functional follow‑up. Document Review: Help review essential startup and study documents, including protocols, ICFs, IBs, pharmacy manuals, monitoring plans, and CRFs. Vendor & CRO Oversight: Manage external partners and CROs to monitor timelines, transferred obligations, and performance expectations. Site & Team Support: Create site feasibility assessments, prepare site newsletters, and assist with site queries in compliance with ICH GCP and study protocols. Data & Milestone Tracking: Track screening, enrollment, data flow, protocol deviations, and clinical trial queries for database locks; prepare status metrics for senior leadership. Issue & Risk Resolution: Proactively identify study risks, recommend solutions, and elevate issues when necessary. Basic Qualifications Education: Bachelor’s degree (BS/BA) or RN in Nursing, Science, or a health‑related field. Experience: 3–5+ years of related experience in Clinical Operations or Medical Affairs. Systems: Familiarity with clinical systems such as CTMS, EDC (e.g., Medidata RAVE), and RDMS. Preferred Qualifications Experience in Oncology / Hematology (Cellular therapy, transplant patient care, or apheresis collection is a strong plus). Study startup experience from a site, CRO, or sponsor background. Working knowledge of ICH GCP standards and FDA treatment‑use/expanded access processes. Strong organizational, analytical, and communication skills within a fast‑paced environment. #J-18808-Ljbffr ATR International