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Senior Clinical Research Associate

i-Pharm Consulting

Location

Remote

Salary

Not specified

Type

fulltime

Posted

Today

via linkedin

Job Description

We are partnering with a large CRO to find an experienced Senior Clinical Research Associate based in the United States for a permanent, full-time position. This is a genuine career opportunity for a seasoned CRA looking to grow long-term within a stable, established organization, rather than a short-term contract.

The Role

You'll manage a portfolio of sites local to your home region, balancing remote monitoring with regular in-person visits (approximately 8 to 10 days onsite per month). Site assignments will be localised to where you are based, so travel stays manageable and sustainable. As a permanent member of the team, you'll take ownership of the full monitoring lifecycle, from site qualification through to close-out, while acting as a trusted point of contact for investigators and site staff, with real opportunity for progression as the CRO's project portfolio grows.

Key Responsibilities

  • Conduct qualification, initiation, interim monitoring, and close-out visits across assigned sites in your local region
  • Perform source document verification, CRF review, and query resolution across paper and EDC systems
  • Ensure ongoing site compliance with ICH-GCP, FDA regulations (21 CFR Parts 50, 56, and 312), and applicable state-level requirements
  • Identify site-level risks proactively and work with sites to resolve issues before they escalate
  • Review subject safety data and informed consent documentation
  • Maintain accurate, timely documentation and TMF filings
  • Oversee IP accountability, storage, and reconciliation at site level
  • Build and maintain strong relationships with investigators, site teams, sponsors, and internal stakeholders
  • Provide mentoring and guidance to junior CRAs as part of a growing internal team
  • Balance a mixed remote/onsite model efficiently, managing your own schedule and local travel

About You

  • Based in the United States, with sites assigned local to your home region, but occasional further travel
  • 5\+ years' CRA experience, with a strong monitoring track record across multiple sites
  • Solid grounding in ICH-GCP and FDA regulatory requirements, including familiarity with IND-related monitoring and IRB processes
  • Confident working independently, with strong self-organisation and time management
  • Comfortable with a hybrid remote/onsite rhythm and regular local travel
  • Experience with CTMS and EDC platforms
  • Excellent written and verbal communication skills
  • Life sciences, nursing, or related degree/qualification
  • Looking for long-term stability and progression within a growing CRO, rather than a short-term or project-based engagement

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