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Alira Health

Where Empathy Meets Science to Accelerate Life Sciences Research

In-House Clinical Research Associate

Research AnalystResearch AnalystFull TimeRemoteMid LevelTeam 501-1,000H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

1 day ago

Salary

$85K - $100K / year

Seniority

Mid Level

Bachelor Degree1 yr expEnglishGoogle Cloud Platform

Job Description

• Manage and support clinical sites from site approval through close-out • Develops study documents and tools, including Informed Consent Form (ICF) templates • Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs • Responds to sites’ regulatory board requests for protocol and ICF clarification as needed • Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment • Analyzes site performance problems (protocol adherence) and identifies solutions • Maintains regular communication with study sites to ensure protocol/GCP compliance • Conducts remote review of data entered on electronic Case Report Forms (eCRFs) • Assists with efforts to recruit investigative sites to participate in clinical studies • Complies with ICH GCP guidelines, FDA regulations, and company SOPs

Job Requirements

  • BS/BA from an undergraduate program or equivalent experience
  • 1-2 years of experience in clinical research
  • Proven ability to be careful, thorough, and detail-oriented
  • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
  • Strong analytical skills
  • Self-starter who thrives in a collaborative, yet less structured team environment
  • Strong command of English, both written and verbal
  • Excellent communication and interpersonal skills with customer service orientation
  • Proficient with MS Office Suite, particularly Word and Excel
  • Permanent authorization to work in the U.S.

Benefits

  • Professional development
  • Global travel
  • Flexible work programs

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