FSP - CRA 2 - Oncology - West Coast

Fortrea is seeking a CRA 2 with strong Oncology monitoring experience to provide high-standard care for participants in clinical trials. The role involves site monitoring, ensuring adherence to protocols, and coordinating clinical projects while maintaining data integrity.

Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data
• Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
• Assist with training of new employees, eg. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
• Perform other duties as assigned by management

Skills

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 1 - 3+ years of Clinical Monitoring experience
• Oncology experience is required
• West Coast location
• 30-40% overnight travel

Benefits

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO) – Flex Plan
• Employee recognition awards
• Multiple ERG’s (employee resource groups)

Company Overview

Company H1B Sponsorship