Senior Clinical Research Associate - US - West Coast - FSP

Overview

Senior Clinical Research Associate on the client's Monitoring team, providing monitoring expertise to individual clinical trials and/or programs.

What you'll do

• Conduct and support in-house and outsourced clinical site monitoring to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs) and study protocols.
• Collaborate with study teams during start-up/feasibility and conduct site identification and assessment tasks.
• Identify root causes and proactively escalate and resolve CRA and site performance issues through collaboration with stakeholders.
• Provide monitoring expertise, mentoring and training to less experienced team members as required.
• Build positive working relationships and proactively seek feedback from site teams (e.g., Principal Investigators, Study Coordinators, Pharmacists, Site Administration).
• Partner with study teams and sites in conducting site outreach activities, including patient recruitment and retention strategies.
• Provide input and lead cross-functional teams through the process to determine monitoring strategy (risk-based monitoring) for studies as required.
• Use regional knowledge to localize study processes and documents where possible.
• Represent Monitoring at Investigator Meetings as required.
• Perform other tasks as required.
• Collaborate effectively with study teams and stakeholders to conduct site assessments, identify performance issues, and implement solutions that align with project goals and operational efficiency.

What you'll need

• Relevant clinical research experience (e.g., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device).
• Working knowledge of GCP, ICH guidelines and FDA regulations.
• 5+ years of relevant monitoring experience.
• Education: BA/BS, nursing degree, or advanced degree.
• Ability to travel domestically.
• Ability to work independently and in a team environment.
• Proficiency with MS Office 365 (e.g., Word, Excel, PowerPoint, Outlook, SharePoint).
• Excellent oral and written communication skills and strong organizational abilities.

Nice to have

• Experience in Oncology.
• Degree in the life sciences.

Details

• Location: United States, California, Remote.
• Domestic travel required.