Senior Clinical Research Coordinator

Patient Care & Visit Execution: Conduct clinical study visits, perform patient screening, execute informed consent procedures, and administer protocol-required follow-up assessments in an outpatient clinic setting. Phlebotomy & Sample Handling: Perform routine blood draws, process specimens, and prepare lab samples for transport according to protocol guidelines. Regulatory & Compliance Management: Draft and submit IRB documents, maintain essential regulatory binders, and ensure continuous adherence to FDA regulations, GCP, and site SOPs. Data & Source Documentation: Record clinical data into Electronic Data Capture (EDC) systems, maintain audit-ready source documentation, and resolve data queries promptly. Safety Tracking & Escalation: Monitor, log, and report Adverse Events (AEs), Serious Adverse Events (SAEs), and protocol deviations within required sponsor and IRB timelines. Sponsor & Monitor Engagement: Facilitate Site Initiation Visits (SIVs), host regular CRA monitoring visits, and coordinate study closeout activities with external sponsors and CROs. Study Startup & Logistics: Manage trial inventory, study supplies, laboratory kits, and investigational product accountability from study initiation through completion. Required Skills 2–3+ Years Active CRC Experience: Proven track record running full clinical trials with minimal supervision (no entry-level/fresh candidates). End-to-End Trial Execution: Complete hands‑on ownership of study lifecycle operations, including patient recruitment, screening, informed consent, EDC entry, and source documentation. FDA & Regulatory Compliance: Direct experience handling FDA-regulated protocols, IRB submissions, regulatory binders, and audit readiness. Phlebotomy Competency: Practical ability to perform routine blood draws and process lab specimens during clinical visits. Independent Study Management: Capability to serve as the sole primary site coordinator, managing 1–2 concurrent studies with high attention to detail and strict adherence to protocol. Preferred Skills Preferred Qualifications & Technical Skills Institutional Background: 2–3+ years at major health systems Core Clinical Skills: Hands‑on phlebotomy and blood collection expertise. Trial Governance: Demonstrated end‑to‑end management of FDA‑regulated and medical device/instrument trials (1–2 active protocols concurrently). Trial Execution: Full lifecycle experience ("soup to nuts") covering study startup, IRB submissions, EDC/source documentation, CRA monitoring visits, and study closeout. Patient Operations: Independent execution of patient recruitment, screening, informed consent, and protocol‑driven follow‑up visits. Work Style: Highly disciplined, detail‑oriented, and capable of operating as the primary site coordinator with minimal oversight. Schedule/Shift Some early mornings or late nights required, flexibility needed #J-18808-Ljbffr