Clinical Research Associate II - FSP
$91,500–$137,300 year
Remote · California, United States or Texas, United States
Job Summary
Clinical Research Associate II (FSP) remote role; responsible for monitoring and site management across clinical studies, start-up and study implementation, on-site and remote monitoring, and related site activities. Duties include ensuring patient safety and data quality, guiding audit-readiness preparations, maintaining trial management tools, and handling regulatory documentation (IRB/EC, informed consent). Responsibilities also cover budget negotiation support, investigator contracts, site initiation/qualification visits, data review (EDC/ISF/TMF), SAE identification and reporting, and travel to sites as needed. Requires independent work within a study team, strong communication, and ability to coordinate with sponsors and trial management teams. Qualifications include a 4-year degree or equivalent, 2+ years of CRA experience (CRO/pharma/biotech), oncology trial experience, proficiency with computerized systems, and ability to travel overnight (up to 60%), with English fluency.
Required Qualifications
- 4-year college degree or equivalent experience in a scientific or healthcare discipline
- Two (2) years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent
- Site management or equivalent experience in clinical research
- Excellent communication and organizational skills
- Experience monitoring oncology trials
- Evidence of a client focused approach
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
- Ability to travel overnight. Up to 60% travel on average, based on regional requirements
- Fluency in English and for non-English speaking countries the local language of country where position based
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