Clinical Research Associate (US-based, West Coast)

Clinical Research Associate (US-based, West Coast)

Division:

Research & Development Department:

Clinical Monitoring Job Classification:

Contract Reports to:

Project Manager, Research & Development Summary:

Provide clinical trial-related monitoring activities including remote and on-site visits to the US sites participating in investigational studies.

Essential Duties and Responsibilities:

Provides site monitoring support for sponsored clinical studies. Performs on-site and remote initiation, routine, and closeout visits. Prepares site visit reports and provides assistance to site staff in resolving deficiencies. Educates and trains site and study staff in management of sponsored studies, including regulatory and ICH/GCP compliance. Collects and processes regulatory documentation for investigational studies in compliance with required guidelines. Develops and demonstrates understanding and application of therapeutic area knowledge to assignments and project-related issues. Appropriately resolves issues related to trial monitoring and management with guidance from the Project Manager, Clinical Monitoring. Makes independent decisions with some supervision from the Senior Director, Research & Development, or the Project Manager, Research & Development. Performs primarily intellectual tasks and exercises discretion and independent judgment.

Qualifications:

Working knowledge of SOPs along with FDA and ICH/GCP guidelines. Good communication, organizational, and writing skills. Develops and applies efficient computer tools to carry out job functions. Attention to detail; ability to work in a team environment. Dependable; assumes responsibility and accepts, supports, and positively facilitates change. Ability and availability to communicate with sites in different US time zones. Willingness to travel. Working knowledge of Microsoft Office suite Working knowledge of clinical trials electronic tools (CTMS, e

TMF, EDC, IRT

).

Education and Experience:

BS/MS/RN or equivalent in scientific or health care field. At least 3 years of pharmaceutical, clinical, or biological research with 2 years of Clinical Research Associate experience in oncology.