Clinical Research Associate II, Oncology

Pharmaron

1d • Remote

About The Position

Pharmaron is seeking an experienced Clinical Research Associate II to support innovative Phase I oncology clinical trials across multiple U.S. sites. In this role, you will lead site monitoring activities from study startup through closeout, ensuring protocol compliance, patient safety, data integrity, and adherence to ICH-GCP and regulatory standards. This is an exciting opportunity to contribute to cutting-edge therapies while partnering closely with investigators, sponsors, and cross-functional clinical teams.

Requirements

• 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
• Ability to independently prioritize workload across multiple sites and studies

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees