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About this opportunity
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. Key Accountabilities 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. Skills: • 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 Knowledge and Experience : • Relevant clinical research experience (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device) • Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations • Experience in Oncology preferred • 5+ years of relevant monitoring experience Education: • BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred #LI-LO1 #LI-REMOTE
What the employer listed
- Pay
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- Eligible locations
- Remote — United States of America