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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