Senior Clinical Research Associate – US West (Remote/Onsite)

Regulatory Jobs

California

Híbrido

USD 72.000 - 145.000

Jornada completa

Hace 6 días
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Ventajas ofrecidas por este puesto de trabajo

Medical and dental plans
Vision plan
Paid time off (PTO)
Parental leave
401(k) retirement plan
Employee Stock Purchase Plan

Descripción de la vacante

Thermo Fisher Scientific in California seeks a Senior Clinical Research Associate (Level I) to lead monitoring activities and site management within a global team. Responsibilities include remote or on-site visits, regulatory compliance, and precise documentation across sponsor environments.

You will ensure trial conduct per protocol and ICH-GCP, manage essential documents, and support team communications while driving data quality and audit readiness. Travel is expected.

Formación

  • Strong knowledge of ICH-GCP, regulations and SOPs.
  • Experience performing clinical monitoring and site management.
  • Bachelor's degree in life sciences or RN qualification.

Responsabilidades

  • Monitor investigator sites with risk-based approach and ensure data quality.
  • Track trial progress and update CTMS with required conventions.
  • Participate in investigator meetings and site initiation.
  • Ensure essential documents are complete per ICH-GCP and regulations.
  • Support project team with publications/tools and CTM tasks.
  • Communicate effectively with sites, client, and project team.
  • Respond to audits/inspections and manage admin tasks.

Conocimientos

ICH-GCP knowledge
Regulatory knowledge
Attention to detail
Communication skills
Teamwork
Microsoft Office proficiency

Educación

Bachelor's degree in life sciences or RN

Herramientas

Microsoft Office

Descripción del empleo

Thermo Fisher Scientific in California seeks a Senior Clinical Research Associate (Level I) to lead monitoring activities and site management within a global team. Responsibilities include remote or on-site visits, regulatory compliance, and precise documentation across sponsor environments.

You will ensure trial conduct per protocol and ICH-GCP, manage essential documents, and support team communications while driving data quality and audit readiness. Travel is expected.

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