Clinical Research Associate

The Position The Position (Phase 1 healthy volunteer studies): CRA/Sr. CRA drives quality clinical research and delivery of monitoring and site management activities, ensuring patient safety/rights and wellbeing, data reliability, scientific integrity, and regulatory/process compliance. Essential Functions Deliver tasks supporting planning and implementation of quality-driven clinical trials. Implement proactive risk identification/mitigation using RBQM; execute Site Selection, Site Initiation, Monitoring, and Closure. Verify safety reporting and proper handling/monitoring/storage of trial product per protocol, SOPs, ICH-GCP, and regulations. Ensure data accuracy, validity, and completeness per protocol/Monitoring Plan. Complete required training; act as local expert in assigned protocols; build therapeutic area knowledge. Drive recruitment and retention to meet enrollment/retention targets. Support audit/inspection activities; develop/implement CAPA. Collaborate and provide input across CDO/CMR/global partners; maintain technical proficiency. Physical Requirements 50–75% overnight travel; valid driver’s license; may work weekends/holidays. Territory: East Coast + Central US (near major airport ideal). Qualifications/Skills 4+ years clinical trial experience (pharma/biotech/CRO/healthcare) required; 2+ years on-site monitoring required (may be waived with relevant GCP Novo Nordisk experience). Bachelor’s degree (science preferred); alternatively RN with 3+ years on-site monitoring. Knowledge of medical terminology and ICH-GCP; ability to balance competing priorities and mitigate risks. Proficiency: MS Office, MS Project, MS PowerPoint. Excellent English communication; collaborative/stakeholder management. Preferred: Phase 1 healthy volunteer monitoring (on-site and remote). Compensation/Benefits Eligible for company bonus; long-term incentive and/or company vehicles (level dependent). Medical/dental/vision, life/disability, 401(k), flex spending, EAP, tuition reimbursement, voluntary benefits. Sick time, flexible vacation, parental leave. Application Instruction If needing accommodation, call View phone number on click.appcast.io (accommodation requests only). #J-18808-Ljbffr