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:
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