Oncology Senior Clinical Research Associate- FSP

When our values align, there's no limit to what we can achieve.
 
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.

Parexel FSP is looking for a Senior CRA/CRA in the United States!

Oncology experience required.

Key Accountabilities  

Supporting Activities 

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. 

Compliance with Parexel standards 

• Complies with required training curriculum  

• Completes timesheets accurately as required  

• Submits expense reports as required  

• Updates CV as required  

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements 

Skills: 

• Travel as required, to include domestic and international  

• 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  

• Ability to speak and understand multiple languag