Senior Clinical Research Associate - US - West Coast - FSP

The Clinical Research Associate (CRA) will be a member of the client’s Monitoring team and provide monitoring expertise to individual clinical trials and/or programs.

Key Accountabilities

Oversight of activities

• Conduct and provide support for in-house and outsourced clinical site monitoring activities 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

Collaborative relationships

• Collaborates effectively with study teams and stakeholders to conduct site assessments, identify performance issues, and implement solutions that align with project goals and operational efficiency.

Skills:

• Ability to travel domestically

• Demonstrates 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

Knowledge and Experience:

• Relevant clinical research experience (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device)

• Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations

• Experience in Oncology preferred

• 5+ years of relevant monitoring experience

Education:

• BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred

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