Senior Clinical Research Associate – Oncology
Location
United States
Posted
2 days ago
Salary
Not specified
Bachelor Degree5 yrs expEnglishGoogle Cloud Platform
Job Description
• 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
Job Requirements
- 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
Benefits
- N/A