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Clinical Research Associate

  • LocationCosta Mesa, CA 92626 - United States
  • Work TypeFull time
  • Positions1 Position
  • Job no: 42697
  • Category: Clinical

CRA: Accountability/Responsibilities Clinical Services For assigned projects and study sites: ? Learns study protocol and develops in-services for assigned site study personnel. ? Performs site study initiation visits, ongoing monitoring visits, and study closeout visits per client-specified procedures. ? Facilitates site protocol compliance and data collection efforts. ? Oversees site study supply inventory. ? Throughout assigned studies, monitors site subject recruitment activities and progress, data collected vs. source documentation, regulatory file maintenance, and protocol compliance. Processes completed Case Report Forms (CRFs) to data entry, and assists with CRF query resolution as necessary per client-specified procedures. ? Develops and maintains organized home office filing systems for study-related documentation for assigned sites. ? Acts as key study liaison for assigned sites. ? Provides regular progress reports concerning assigned sites and participates in project review meetings as requested by Project Manager. ? Assists Project Manager with GCP audits or training programs. Provides support for assigned sites with FDA Bioresearch Monitoring inspections. Study Monitoring 90% Administrative 10% Experience/Skills Recommended for Position: ? Thorough understanding of Good Clinical Practice. ? Thorough understanding of FDA regulations regarding conduct of clinical studies, procurement of informed consent, and IRB responsibilities ? Detailed knowledge of general medical terminology. ? Strong communication skills as demonstrated via telephone interactions, personal presentations, and general written correspondence. ? Well-organized, with strong attention to detail, documentation, and follow-through. ? Ability to independently complete assigned project activities. ? Proven ability to establish professional rapport with clients, contractors, and/or study site personnel. ? Proficiency with Windows, Word, Excel, and Access software. ? Ability to travel frequently using air/ground transportation; work in varied environments; lift, pack, and carry study materials; stand for filing, copying, faxing, and collation of study materials. ? BS or BA degree. ? 2 years minimum related experience.