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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Clinical Research Associate - US - West Coast - FSP
Job ID R0000046413The 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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