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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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.