Senior Clinical Research Associate - Oncology - FSP

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Research Associate – Oncology – FSP based in the United States.

In this role, you will take ownership of site monitoring activities across oncology clinical trials, ensuring studies are executed with the highest standards of quality, compliance, and patient safety. You will act as the primary liaison between clinical trial sites and internal study teams, supporting investigators throughout all phases of the study lifecycle. From site selection and initiation to monitoring and close-out, you will ensure adherence to regulatory requirements and study protocols. This position requires strong autonomy, advanced monitoring expertise, and the ability to manage complex oncology studies in a fast-paced environment. You will collaborate closely with cross-functional teams, contributing to patient recruitment, data integrity, and operational excellence. The role offers the opportunity to work on impactful clinical research programs that advance innovative oncology therapies.

• Lead site management activities including selection support, initiation, monitoring, and close-out of clinical trial sites in accordance with study protocols and regulatory requirements.
• Conduct on-site and remote monitoring visits, including source data verification (SDV), source data review (SDR), and Case Report Form (CRF) review as per monitoring plans.
• Ensure compliance with ICH-GCP guidelines, study protocols, client SOPs, and applicable regulatory requirements throughout all study activities.
• Serve as the primary point of contact for assigned sites, providing training, guidance, and ongoing support to investigators and site staff.
• Perform risk-based site assessments and adjust monitoring strategies to ensure quality and compliance.
• Track study progress, update clinical systems (e.g., CTMS), and ensure timely resolution of data queries and outstanding actions.
• Manage investigational product accountability, study supplies, and ensure proper handling and documentation at site level.
• Support Serious Adverse Event (SAE) reporting and ensure timely follow-up and documentation of safety information.
• Prepare, finalize, and submit monitoring visit reports, follow-up letters, and ensure all required documentation is complete and audit-ready.
• Participate in study team meetings, contribute to recruitment strategies, and escalate site issues or quality risks as needed.
• Ensure inspection readiness of sites and proper maintenance of essential documents within the eTMF.

Requirements

• Bachelor’s degree in a scientific, life sciences, or healthcare-related field.
• Minimum of 5+ years of clinical monitoring / CRA experience in a CRO or pharmaceutical environment.
• At least 2+ years of oncology monitoring experience required.
• Strong knowledge of ICH-GCP guidelines, clinical trial processes, and applicable regulatory requirements.
• Experience with risk-based monitoring approaches, including remote and on-site monitoring activities.
• Ability to perform SDV, SDR, CRF review, and manage complex site-level documentation.
• Strong understanding of clinical study management, including drug accountability and data integrity principles.
• Excellent communication, interpersonal, and relationship-building skills with site personnel and internal teams.
• Strong organizational skills with the ability to manage multiple studies and competing priorities.
• Proficiency in English (written and spoken); additional local language fluency is an advantage.
• Willingness to travel as required for site visits and study responsibilities.
• Strong problem-solving skills, attention to detail, and ability to work independently in a remote and global team environment.

Benefits

• Competitive annual compensation aligned with experience and market standards.
• Comprehensive healthcare coverage, including medical, dental, and vision insurance.
• Paid time off, holidays, and additional leave benefits.
• Retirement savings programs and financial wellbeing support.
• Opportunity to work on high-impact oncology clinical trials within a global research environment.
• Career development opportunities within clinical operations and clinical research leadership paths.
• Exposure to innovative therapies and advanced clinical trial methodologies.
• Collaborative and international working environment with cross-functional teams.
• Flexible work arrangements depending on study and travel requirements.