FSP - Sr. CRA 2 - Oncology - West Coast

Role Summary

The Senior CRA 2 is responsible for site monitoring and site management in clinical studies, operating according to Fortrea, Sponsor SOPs, and Regulatory Guidelines. This role implements project plans, may lead projects of limited scope, and may assume line management or Local Project Coordinator/Lead CRA duties as assigned.

Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring and closeout 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 Responsibilities: ensure staff have materials and instructions to enter patients into the study; ensure patient protection by adhering to informed consent procedures and protocol requirements; ensure data integrity through source document review; monitor data for missing or implausible data.
• Manage travel and resources efficiently according to SOPs and travel policy; maintain audit readiness at the site level; travel may be required and is essential.
• Prepare accurate and timely trip reports; manage small projects under supervision; serve as lead monitor for a protocol or project as assigned; review progress and take actions to achieve objectives.
• Organize Investigator Meetings; participate in protocol and Case Report Form development; contribute to writing clinical trial reports; interact with internal groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and vendors; manage registry aspects as prescribed; conduct feasibility work when requested; conduct QC visits; recruit investigators and assist with regulatory submissions and budget negotiations.
• Track and follow-up on Serious Adverse Event (SAE) reporting; perform CRF review and query resolution; assist with training and mentoring of staff; coordinate designated clinical projects as Local Project Coordinator or client contact as assigned.

Qualifications

• Required: University or college degree (life science preferred) or related allied health certification; or minimum 3 years relevant clinical research experience in pharmaceutical or CRO industries; thorough knowledge of regulatory requirements and drug development; fluency in local language and English; valid driver‚Äôs license; Fortrea may consider equivalent experience.
• Preferred: Additional related field experience (medical, clinical, pharmaceutical, data analysis, etc.); local project coordination or project management experience.

Experience

• 5+ years of Clinical Monitoring experience.
• Strong understanding of SAE reporting and data processing; advanced site monitoring and site management skills; advanced registry administration skills.
• Ability to work with minimal supervision; strong planning, organization, and communication skills; ability to train and supervise junior staff; ability to work in a matrix environment; valid driver‚Äôs license.

Additional Requirements

• Travel requirements: 30-40%+ overnight.
• Physical demands: ability to sit for extended periods, occasional lifting up to 15-20 lbs, repetitive hand movements, and other duties as essential to the role.