Clinical Trial Assistant

Intuitive; Sunnyvale (CA); In loco; USD 65.000 - 85.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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.

Conoscenze

Regulatory compliance

Documentation control

Budget tracking

Administrative support

Study coordination

CTMS usage

Strumenti

TMF management

CTMS

Descrizione del lavoro

Job Description

Primary Function of Position:

The Clinical Trial Assistant will play a key role to provide operational support to coordinate the conduct and management of clinical studies to ensure compliance with Intuitive standard operating procedures, Good Clinical Practices (GCP), good documentation practices, and applicable regulations. The ideal candidate will have good understanding of clinical trials regulatory requirements. This position is based at the Intuitive Surgical Headquarters in Sunnyvale, California.

Roles & Responsibilities:

• Coordinate and manage the ordering, shipping, labeling and tracking of study supplies (including investigational products) with limited supervision
• Establish, organize and maintain trial master file and clinical trial management system to ensure regulatory and protocol compliance including maintenance of study essential documentation (e.g., correspondence, CRFs, study approval documents, curriculum vita, etc…), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.)
• Contribute to operational excellence and continuous improvement
• Maintain, track and facilitate routing for approval and signature of clinical study documents including protocols, case report forms, Informed consents, Clinical trial agreements, non-disclosure agreements, etc
• Create purchase requests and process invoices
• Support clinical study manager with study budget tracking and payments of clinical sites and vendors
• Prepare and ship site binders and patient binders as necessary
• Contribute to creating clinical study informational materials such as newsletters, recruitment materials, etc.
• Collaborate with Clinical Study Managers (CSM) to develop clinical study informational materials such as newsletters, recruitment materials, etc
• Collaborate with Clinical Research Associates (CRA), Clinical Study Managers (CSM) and Clinical Managers to support study execution
• Provide administrative support to coordinate, schedule and plan study and investigators meetings, teleconferences, distributing agendas and meeting minutes