Senior Clinical Research Associate - Remote & Travel

Kelly Science, Engineering, Technology & Telecom

Nevada

Remote

USD 80,000 - 88,000

Full time

4 days ago
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Job summary

Kelly Science & Clinical is seeking a Senior Clinical Research Associate for a six-month, full-time contract position. This remote, home-based role supports regional clinical studies across the Western U.S.

You will independently monitor clinical trial sites to ensure studies follow protocols, ICH-GCP guidelines, and regulations, with regular communication to project teams. The position involves risk-based monitoring, data verification, site management, and supporting audit readiness.

Qualifications

  • Bachelor’s degree in a life science-related field.
  • 3+ years of on-site CRA monitoring experience as the primary monitor.
  • Experience monitoring complex drug studies in oncology, CAR-T, rare disease, neurology, or infectious disease.
  • Strong understanding and practical application of ICH-GCP, applicable regulations, and study procedures.
  • Experience with risk-based monitoring, source document review and verification, EDC, and CTMS platforms.
  • Valid driver’s license and ability to travel regionally up to 80% as needed.

Responsibilities

  • Conduct remote and on-site monitoring visits using risk-based monitoring practices.
  • Review source documents, verify study data, and review case report forms for accuracy and completeness.
  • Assess investigational product inventory and related records.
  • Confirm that site activities and essential documents comply with study protocols, ICH-GCP guidelines, applicable regulations, and project procedures.
  • Identify site issues, document findings in monitoring reports and follow-up letters, escalated deficiencies, and track issues through resolution.
  • Maintain regular communication with investigative sites, client teams, and project colleagues.
  • Support site selection, initiation, ongoing management, and close-out activities.
  • Maintain study tracking systems, such as CTMS, and provide study status updates to the Clinical Team Manager.
  • Support audit readiness and respond to audit, inspection, and quality requirements.
  • Complete required administrative tasks, including timesheets and expense reports.
  • Mentor newer team members and support project tools, training, and process-improvement efforts as needed.

Skills

Risk-based monitoring
On-site monitoring
Site management
Data review & CRF verification
Communication with sites/teams
Travel up to 80%

Education

Bachelor’s degree in life science

Tools

EDC
CTMS

Job description

Kelly Science & Clinical is seeking a Senior Clinical Research Associate for a six-month, full-time contract position. This remote, home-based role supports regional clinical studies across the Western U.S.

You will independently monitor clinical trial sites to ensure studies follow protocols, ICH-GCP guidelines, and regulations, with regular communication to project teams. The position involves risk-based monitoring, data verification, site management, and supporting audit readiness.

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