Senior CRA I — Remote, High Travel Contract

Actalent

United States

Remote

USD 81,000 - 86,000

Full time

5 days ago
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Benefits offered by this job

Medical, dental & vision
401(k) Retirement Plan
Life Insurance
Disability insurance
Health Spending Account (HSA)
Transportation benefits
PTO / Vacation

Job summary

Actalent is seeking a Senior Clinical Research Associate I (Sr CRA I) for a 6-month contract based in Santa Clara, CA, with 60–80% travel and full remote work option. The role emphasizes monitoring, site management, and regulatory compliance across global trials.

Competitive pay and full benefits are provided for a W2 arrangement. The Sr CRA I will conduct remote and on-site visits, ensure data integrity, and maintain audit-ready documentation while collaborating with sponsor teams and project

Qualifications

  • Bachelor's degree in life sciences or RN with relevant experience.
  • At least 2 years' experience as a clinical research monitor.
  • Valid driver's license where travel is required.
  • Strong understanding of ICH-GCP and regulatory requirements.
  • Experience in monitoring oncology or CNS trials is a plus.
  • Excellent documentation and audit-readiness skills.
  • Effective written and verbal communication with sites and teams.

Responsibilities

  • Perform monitoring and site management remotely and on-site.
  • Apply risk-based monitoring and drive corrective actions.
  • Verify data accuracy via SDR/SDV/CRF reviews.
  • Ensure product accountability and regulatory compliance.
  • Document observations in audit-ready reports and correspondence.
  • Escalate site issues and drive timely resolutions with teams.
  • Maintain regular contact with sites between visits.
  • Follow the monitoring plan and SOPs precisely.
  • Support investigator meetings and site training.
  • Identify potential investigators with sponsor teams.
  • Assist in trial close-out and essential document filing.
  • Update CTMS and other study systems as needed.
  • Contribute to project tools, newsletters, and publications.
  • Lead or support CRA team calls and coordination.

Skills

Remote monitoring
On-site monitoring
Risk-based monitoring
Data integrity checks
SDR/SDV/CRF reviews
ICH-GCP knowledge
Site management
Documentation quality
Communication with teams
Project coordination
CTMS proficiency
Time management
Audit readiness
Regulatory compliance
Travel readiness
Team collaboration
Clinical research knowledge
Oncology and CNS knowledge

Education

Bachelor's degree in life sciences
Registered Nursing certification

Tools

CTMS
Microsoft Office

Job description

Actalent is seeking a Senior Clinical Research Associate I (Sr CRA I) for a 6-month contract based in Santa Clara, CA, with 60–80% travel and full remote work option. The role emphasizes monitoring, site management, and regulatory compliance across global trials.

Competitive pay and full benefits are provided for a W2 arrangement. The Sr CRA I will conduct remote and on-site visits, ensure data integrity, and maintain audit-ready documentation while collaborating with sponsor teams and project

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