Note: The job is a remote job and is open to candidates in USA. BioTalent is a growing clinical development organization seeking a Senior Clinical Research Associate to support the delivery of complex clinical trials across multiple therapeutic areas. This remote-based role requires candidates to be based on the West Coast, East Coast, or Texas and involves significant travel to investigative sites.
Responsibilities
- Conduct site monitoring visits, including SSVs, SIVs, interim monitoring visits, and close-out visits
- Act as the main point of contact for assigned sites, ensuring strong communication and timely issue resolution
- Monitor site compliance with the protocol, ICH-GCP, regulatory requirements, and study-specific procedures
- Perform SDV/SDR activities and support data quality, query resolution, and timely eCRF completion
- Identify, document, and escalate protocol deviations, risks, and quality concerns
- Maintain accurate and inspection-ready site documentation in CTMS, eTMF, EDC, and other study systems
- Support patient recruitment, retention, and site performance activities
- Prepare monitoring visit reports, follow-up letters, and action plans within 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 related discipline
- Prior independent on-site monitoring experience within a CRO, Pharma, or Biotech environment
- Experience with rare disease/orphan disease and/or oncology is required
- 4–5 years of independent on-site monitoring experience within a CRO, Pharma, 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, EDC, 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 driver's license
- Must be based on the West Coast
- Pediatric or NICU experience would be highly preferred
- Nursing background is ideal
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