Clinical Research Associate (Oncology)

Overview

This role involves acting as the main contact and manager for clinical trial sites through all stages of the study, specifically requiring oncology experience and focusing on US-based locations. The Clinical Research Associate (CRA) ensures efficient site management and compliance with clinical study protocols and regulatory requirements.

Key Responsibilities

• Establish and maintain strong, continuous relationships with clinical trial sites throughout the study.
• Execute site monitoring and management duties compliant with ICH/GCP guidelines, Sponsor SOPs, local laws, protocols, and monitoring plans.
• Thoroughly understand study protocols and related procedures to effectively manage site tasks.
• Collaborate with sponsor teams to coordinate site readiness activities.
• Engage in site selection and validation processes.
• Conduct both remote and on-site monitoring visits (validation, initiation, monitoring, closeout), documenting comprehensive reports timely.
• Ensure data integrity: accuracy, completion, and impartiality of site-generated data.
• Protect safety, rights, and welfare of study participants.
• Manage and review regulatory documentation throughout study start-up, maintenance, and close-out phases.
• Communicate effectively with investigators and site teams on protocol adherence, recruitment, retention, deviations, documentation, audits, and site performance issues.
• Identify and resolve site-related quality or compliance challenges; escalate as needed following established pathways.
• Maintain up-to-date entries in clinical trial management systems, electronic trial master files, and related platforms per deadlines.
• Provide mentorship and share expertise within the CRA team to foster knowledge sharing and best practices.
• Support or lead audit and inspection activities; perform co-monitoring visits when appropriate.
• Adhere to all company standards including required training, timesheet and expense report submissions, CV updates, and compliance with internal processes and external regulations.
• Travel domestically and internationally is expected approximately 65% to 75% of work time, averaging 2-3 days per week. A current driver’s license is required.

Required Skills and Qualifications

• Fluent verbal and written communication skills in English and local languages.
• Solid understanding of clinical research phases, GCP/ICH guidelines, and applicable country-specific regulations.
• Strong knowledge of global and regional clinical research standards with the ability to operate within those frameworks.
• Proficiency in Good Documentation Practices and clinical IT applications across multiple devices.
• Demonstrated expertise in site management, including performance oversight and patient recruitment.
• High competency in monitoring with sound independent professional judgment.
• Analytical skills to interpret data and metrics with appropriate action planning.
• Problem-solving capabilities encompassing root cause analysis and implementation of corrective and preventive actions.
• Excellent time management, organizational, interpersonal, and conflict resolution skills.
• Ability to work independently across multiple protocols and therapy areas with a sense of urgency and accountability.
• Experience working effectively in multicultural, matrixed environments.
• Customer-centric approach with a commitment to quality, compliance, and professional communication.
• Self-motivated with a positive, growth-oriented mindset.

Experience and Education

• A minimum of two years of direct clinical site monitoring experience in bio/pharmaceutical or CRO settings.
• Bachelor’s degree preferred, ideally with a focus on science or biology.

Additional Information

Oncology experience is mandatory for all locations. Specific therapeutic area or monitoring experience requirements may vary depending on study or country needs.