Medical Affairs Associate

Work Arrangement: Fully Remote

We are looking for an experienced Medical Affairs Associate to support Medical Affairs and Clinical Operations activities, including Expanded Access Programs, Out-of-Specification (OOS) case support, and Single-Patient IND processes.

This is an exciting opportunity for a clinical operations professional with experience in clinical trial management, vendor coordination, study execution, and cross-functional collaboration.

• Support clinical trials from study start-up through closeout.
• Coordinate Expanded Access Programs, OOS programs, and Single-Patient IND activities.
• Manage CROs, vendors, external partners, and study-related deliverables.
• Support review of essential study documents, including protocols, ICFs, IBs, and monitoring plans.
• Track study milestones, enrollment, data flow, risks, and protocol deviations.
• Coordinate site and investigator communications and resolve routine study-related queries.
• Prepare program metrics, status reports, and management updates.
• Ensure compliance with ICH-GCP, applicable regulations, and internal procedures.
• Bachelor's degree in Nursing, Life Sciences, or a related healthcare field.
• 3–5 years of relevant Clinical Operations experience.
• Prior experience managing or supporting clinical trials.
• Familiarity with clinical systems such as CTMS, EDC, and RDMS.
• Strong organizational, analytical, communication, and problem‑solving skills.
• Cellular therapy experience.
• Experience with iMedidata/RAVE EDC.
• Study start-up experience in a CRO, sponsor, or site-based regulatory environment.
• Knowledge of transplant patient care and apheresis collection.