Clinical Research Associate – Oncology

This is a fully remote position, open to applicants in Maryland, +1 more state.

📋 Description

• Serve as the main site contact and site manager throughout all stages of a clinical research study.

• Build and maintain strong relationships with site personnel to ensure continuity across all trial phases.

• Conduct clinical study site management and monitoring tasks in adherence to ICH/GCP, sponsor SOPs, local laws and regulations, protocols, and monitoring plans.

• Acquire a comprehensive understanding of study protocols and associated procedures.

• Coordinate efforts with sponsor roles to achieve Site Ready status.

• Engage in site selection and validation processes.

• Carry out both remote and on-site monitoring and oversight activities.

• Ensure that site data is complete, accurate, and impartial.

• Safeguard the rights, safety, and well-being of study subjects.

• Execute validation, initiation, monitoring, and closeout visits, while preparing timely and precise reports.

• Gather, review, and oversee regulatory documentation for study initiation, maintenance, and closure.

• Communicate effectively with investigators and site staff regarding protocol execution, recruitment, retention, deviations, regulatory documentation, audits/inspections, and site performance.

• Identify, evaluate, resolve, and escalate any issues related to site performance, quality, or compliance.

• Manage information and documentation in CTMS, eTMF, and other relevant systems.

• Enhance CRA team knowledge as a process subject matter expert, mentor, and by sharing best practices.

• Assist or lead audit and inspection activities.

• Conduct co-monitoring visits when applicable.

⛳️ Requirements

• Proficient in local languages and English, both verbal and written.

• Solid understanding and practical knowledge of clinical research, clinical trial phases, current GCP/ICH, and relevant country clinical research laws and guidelines.

• Good grasp of Global, Country/Regional Clinical Research Guidelines.

• Practical knowledge of Good Documentation Practices.

• Proven site management capabilities, including site performance and patient recruitment.

• Demonstrated high level of monitoring expertise with independent professional judgment.

• Strong IT skills, including proficiency in MS Office and clinical IT applications.

• Capability to understand and analyze data/metrics.

• Ability to navigate complex issues and adopt a solution-oriented approach.

• Skills in root cause analysis and preventive/corrective actions.

• Effective time management, organizational, interpersonal, conflict management, and problem-solving abilities.

• Capacity to work independently across multiple protocols, sites, and therapeutic areas.

• Proficiency in prioritizing and managing multiple tasks simultaneously.

• Ability to thrive in a matrix multicultural environment.

• Dedication to customer focus and quality/compliance.

• Willingness to travel domestically and internationally approximately 65%-75% of working time; expected travel is about 2-3 days per week.

• A valid driver's license is required.

• At least 2 years of direct site monitoring experience in the bio/pharma/CRO sector.

• Experience in oncology monitoring is essential.

• A bachelor’s degree is preferred, particularly with a strong focus in science and/or biology.

🏝️ Benefits

• Full-time employment.

• Remote work arrangement.

• Equal opportunity employment.