Senior Clinical Research Associate - Oncology - 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.

Job Summary:

The Senior Clinical Research Associate (Sr CRA) will be a member of the Monitoring team and provide monitoring expertise to individual clinical trials and/or programs.

Key Accountabilities:  

• 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  

Required Knowledge, Skills, and Abilities:  

• 5+ years monitoring experience in clinical research experience required (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO)) 

• Oncology monitoring experience required 

• Travel as required, to include domestic and international  

• Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations 

• 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  

Education:  

• BA/BS, nursing degree, or advanced degree required. Degree in the life sciences preferred  

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.