Senior Clinical Research Associate

Research AnalystResearch AnalystFull TimeRemoteTeam 501-1,000Since 2001H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

31 days ago

Salary

$114.0K - $132.7K / year

Bachelor Degree7 yrs expEnglishGoogle Cloud Platform

Job Description

• Independently manage assigned clinical trial sites from start-up through close-out • Perform site qualification, initiation, routine monitoring, and close-out visits • Ensure subject safety, data integrity, and protocol compliance at all assigned sites • Review source documentation, CRFs, and EDC entries for accuracy, completeness, and timeliness • Serve as the primary point of contact for investigators and site staff • Build strong, collaborative relationships with site teams • Identify site performance issues early and implement corrective actions • Ensure compliance with ICH GCP, FDA regulations, ISO 14155 (as applicable), and internal procedures • Support audits and inspections as a subject matter expert • Mentor and provide functional guidance to junior CRAs and CTAs • Partner closely with Clinical Operations, Quality, Regulatory, Data Management, and Medical Affairs

Job Requirements

  • Bachelor’s degree in life sciences, nursing, or related field (Master’s preferred)
  • 7–10+ years of progressive clinical research experience as a CRA
  • Demonstrated ability to manage sites independently with minimal supervision
  • Extensive experience monitoring Phase I–IV clinical trials and/or medical device studies
  • Strong working knowledge of ICH GCP, FDA regulations, and applicable ISO 14155 standards
  • Proven experience supporting audits and regulatory inspections
  • Prior experience serving as a Lead CRA or Senior CRA on multiple studies (preferred)
  • Experience mentoring or leading junior CRAs (preferred)
  • Medical device and/or reimbursement study experience (preferred)

Benefits

  • Health, dental, and vision insurance
  • 401(k) plan plus employer contribution and match
  • Generous paid leaves, including vacation and sick leave
  • Paid volunteer time
  • Annual performance bonus incentive plan
  • Competitive company-sponsored benefits and wellbeing programs

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