Clinical Research Associate II - Riyadh, Saudi Arabia

About the Role

Join our global clinical research team as a Clinical Research Associate Level II. You will support clinical trials by monitoring and managing investigational sites either remotely or onsite to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice guidelines. Your role involves facilitating quality data collection, overseeing trial compliance, and ensuring the rights and safety of study subjects.

Key Responsibilities

• Conduct monitoring visits using a risk-based approach to identify and address site compliance issues through root cause analysis and problem-solving.
• Review source documents, case report forms, and investigational product records for accuracy during both remote and onsite monitoring.
• Prepare timely reports and correspondence documenting monitoring observations, escalating issues for resolution as needed.
• Maintain communication with sites between visits to ensure ongoing protocol compliance and data quality.
• Participate in investigator meetings and assist in site identification and qualification in coordination with clients.
• Manage trial initiation and close-out processes, ensuring all essential documents are complete per regulatory standards.
• Provide regular progress reports and update clinical trial management systems as per project requirements.
• Serve as liaison among investigative sites, project teams, and clients to facilitate effective communication.
• Respond to audits and inspections adhering to company, client, and regulatory standards.
• Complete administrative functions such as expense reporting and timesheets punctually.
• Contribute to project publications, tools, and process improvement initiatives within the team.

Qualifications and Experience

• Bachelor’s degree in life sciences or a Registered Nursing qualification, or equivalent relevant vocational credentials.
• Minimum one year of clinical research monitoring experience or successful completion of a recognized Drug Development Fellowship.
• Valid driver’s license as required for travel.

Skills and Abilities

• Proficient clinical monitoring expertise and medical terminology knowledge.
• Strong understanding of ICH-GCP guidelines and applicable regulatory frameworks.
• Excellent critical thinking and root cause analysis capabilities.
• Competent in managing Risk Based Monitoring processes.
• Effective oral and written communication skills, able to engage with medical professionals.
• Customer-focused with attentive listening and problem-identifying abilities.
• Good organizational, time management, and interpersonal skills.
• Detail-oriented and adaptable to evolving scenarios.
• Capable of working independently or collaboratively within a team.
• Solid computer literacy, especially in Microsoft Office; aptitude for learning clinical software.
• Fluent Arabic speaker with proficient English language and grammar.
• Strong presentation abilities.

Work Environment

• Standard office or clinical/laboratory setting with exposure to electrical equipment.
• Frequent travel to sites (60-80%), including occasional overnight stays.
• Potential exposure to biological fluids and infectious agents requiring personal protective equipment.
• Rare exposure to extreme or fluctuating temperatures.

Work Schedule

Regular Monday through Friday schedule.