[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 clinical trials 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 valid 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