Clinical Research Associate, Sponsor Dedicated

Responsibilities: Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP Coordinate subject recruitment plans with sites to meet project needs Administer protocol training and maintain regular site communication on project expectations Evaluate site practices for protocol conduct and regulatory adherence; escalate quality issues Track regulatory submissions, approvals, recruitment, CRF completion, data queries; may support start-up Ensure TMF/ISF documents are filed and maintained per GCP and local requirements Document site management activities via visit reports, follow-up letters, and required study docs Collaborate with study team members for project execution support Support development of site-specific recruitment plans and, if applicable, site financial management

Key requirements: At least 2 years of independent on-site monitoring experience as a CRA in a CRO, sponsor, or similar setting Good knowledge of GCP and ICH guidelines Experience with EDC, CTMS, eTMF, IVRS/IWRS and other clinical trial systems Proficiency with Microsoft Word, Excel, PowerPoint; ability to work with laptop and mobile devices Strong written and verbal English communication skills Strong organizational and problem-solving abilities Ability to build effective working relationships with coworkers, managers, and clients Bachelor's Degree in scientific discipline or health care preferred strong communication problem-solving time management EDC CTMS eTMF