Senior Clinical Research Associate — Trials & Site Lead

Arrowhead Pharmaceuticals, Inc.; San Diego (CA); In loco; USD 125.000 - 135.000; Tempo pieno

Descrizione del lavoro

Arrowhead Pharmaceuticals, Inc. in the United States is seeking a Sr. Clinical Research Associate (Sr.

CRA) to support study planning, execution, and management. The role focuses on study setup, oversight, and closeout in compliance with the protocol, regulatory requirements, ICH GCP guidelines, and Arrowhead's policies. You will monitor TMF readiness, assist in site selection and activation, coordinate with CROs and labs, review documents for accuracy, and contribute to study-level templates

Competenze

• 5 years in clinical research and development.
• 3 years onsite monitoring/site management.
• Strong knowledge of ICH-GCP.

Mansioni

• Support TMF setup, maintenance, and reconciliation.
• Routinely monitor TMF inspection readiness.
• Review invoices for assigned studies.
• Contribute to Pharmacy Manual and templates.
• Assist in investigational product management and supplies reconciliation.
• Support IRT system setup, testing, and activation.

Conoscenze

ICH-GCP knowledge

onsite monitoring

Study coordination

Strumenti

Veeva eTMF

Medidata EDC

Descrizione del lavoro

Arrowhead Pharmaceuticals, Inc. in the United States is seeking a Sr. Clinical Research Associate (Sr.

CRA) to support study planning, execution, and management. The role focuses on study setup, oversight, and closeout in compliance with the protocol, regulatory requirements, ICH GCP guidelines, and Arrowhead's policies. You will monitor TMF readiness, assist in site selection and activation, coordinate with CROs and labs, review documents for accuracy, and contribute to study-level templates