Senior Clinical Research Associate - US - West Coast - FSP
About The Position
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. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Requirements
- 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
- Relevant clinical research experience (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device)
- Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations
- 5+ years of relevant monitoring experience
Nice To Haves
- Experience in Oncology preferred
Responsibilities
- 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
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
