Clinical Research Associate II, Oncology

About the role

Pharmaron is seeking an experienced Clinical Research Associate II to support innovative Phase I oncology clinical trials across multiple U.S. sites.

Key Responsibilities

• Independently manage and monitor assigned Phase I oncology clinical trial sites from study startup through closeout.
• Conduct all required site visits, including Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
• Ensure studies are conducted in accordance with approved protocols, ICH-GCP guidelines, sponsor requirements, and applicable regulatory standards.
• Perform source data verification (SDV), review eCRFs/CRFs, and ensure accuracy, completeness, and timeliness of clinical trial data.
• Build and maintain effective working relationships with investigators, coordinators, and site personnel.
• Monitor patient safety processes, including timely review and escalation of adverse event and serious adverse event reporting.
• Identify site risks, protocol deviations, and operational issues, and drive timely resolution and corrective actions.
• Maintain inspection readiness through oversight of essential documents, regulatory files, and site compliance activities.
• Ensure investigational product accountability and proper handling procedures, when applicable.
• Prepare monitoring reports, follow-up letters, and visit documentation within required timelines.
• Maintain accurate and current updates in CTMS, eTMF, and other clinical systems.
• Collaborate cross-functionally with Project Managers, Clinical Trial Managers, and sponsors to communicate site progress and study milestones.

What We are Looking for

• Bachelor's degree, RN, or equivalent combination of education and relevant experience; life sciences background preferred
• 3+ years of clinical monitoring experience within sponsor, CRO, or investigative site environments
• Hands-on oncology monitoring experience required, including Phase I studies
• Strong knowledge of ICH-GCP guidelines and applicable regulatory requirements
• Ability and willingness to travel up to 30% based on study needs
• Excellent organizational skills with strong attention to detail
• Strong communication skills and ability to manage site relationships effectively
• Experience using CTMS, EDC, eTMF, and other clinical trial systems
• Experience in early-phase startup environments
• Able to independently prioritize workload across multiple sites and studies

Why Pharmaron?

To learn more about Pharmaron, visit www.pharmaron.com.

Benefits

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

How to Apply

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development.