Clinical Trials Operations Coordinator

Intuitive; Sunnyvale (CA); Sur place; USD 65 000 - 85 000; Plein temps

Résumé du poste

Intuitive Surgical Headquarters in Sunnyvale, CA is seeking a Clinical Trial Assistant to provide operational support for clinical studies, ensuring compliance with GCP, SOPs and regulations. The role involves coordinating supplies, maintaining the TMF/eTMF, and assisting with budgets and study documentation.

The position located at the Sunnyvale campus emphasizes collaboration with CSMs, CRAs and other study teams.

Qualifications

• Familiarity with GCP and SOPs.
• Understanding of clinical trial regulatory requirements.
• Experience with study budgets and payments to sites/vendors.

Responsabilités

• Coordinate ordering, shipping, labeling and tracking of study supplies.
• Maintain trial master file and eTMF to ensure regulatory and protocol compliance.
• Contribute to operational excellence and continuous improvement.
• Facilitate routing for approval and signature of study documents (protocols, CRFs, consents, agreements).
• Create purchase requests and process invoices.
• Support study manager with budget tracking and payments to sites/vendors.
• Prepare and ship site and patient binders as needed.
• Create clinical study materials such as newsletters and recruitment materials.
• Collaborate with CSMs, CRAs and other team members to support study execution.
• Coordinate, schedule and plan meetings and distribute agendas/minutes.

Connaissances

Regulatory compliance

Documentation control

Budget tracking

Administrative support

Study coordination

CTMS usage

Outils

TMF management

CTMS

Description du poste

Intuitive Surgical Headquarters in Sunnyvale, CA is seeking a Clinical Trial Assistant to provide operational support for clinical studies, ensuring compliance with GCP, SOPs and regulations. The role involves coordinating supplies, maintaining the TMF/eTMF, and assisting with budgets and study documentation.

The position located at the Sunnyvale campus emphasizes collaboration with CSMs, CRAs and other study teams.