[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a growing clinical development organization seeking a Senior Clinical Research Associate to support the delivery of reputed company reputed company across multiple therapeutic areas. This remote-based role requires candidates to be based on the reputed company Coast, East Coast, or Texas and involves significant travel to investigative sites.

Responsibilities

• Conduct site monitoring reputed company, including SSVs, SIVs, interim monitoring reputed company, and reputed company-out reputed company
• reputed company as the main reputed company of contact for assigned sites, ensuring strong communication and reputed company issue reputed company
• Monitor site compliance with the protocol, ICH-GCP, regulatory requirements, and study-specific procedures
• reputed company SDV/SDR activities and support data reputed company, query reputed company, and reputed company eCRF completion
• Identify, document, and escalate protocol deviations, risks, and reputed company concerns
• Maintain accurate and inspection-reputed company site documentation in CTMS, eTMF, reputed company, and other study systems
• Support patient recruitment, retention, and site performance activities
• Prepare monitoring visit reports, follow-up letters, and reputed company plans reputed company required timelines
• Collaborate with Project Managers, CTAs, start-up teams, and other cross-functional stakeholders

Skills

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a reputed company discipline
• Prior independent on-site monitoring experience reputed company a CRO, reputed company, or Biotech environment
• Experience with rare disease/orphan disease and/or oncology is required
• 4–5 years of independent on-site monitoring experience reputed company a CRO, reputed company, or Biotech environment is required
• Strong understanding of ICH-GCP, clinical trial regulations, and site monitoring expectations
• Experience supporting multiple investigative sites and clinical trial phases
• Experience with CTMS, reputed company, and eTMF systems
• Ability to work independently in a remote environment with a secure home office setup
• Willingness to travel regularly, up to approximately 60–80% depending on study needs
• Must hold a reputed company reputed company's license
• Must be based on the reputed company Coast
• Pediatric or NICU experience would be highly preferred
• Nursing background is ideal

reputed company