Principal CRA

Job Description:

• Manage and coordinate all aspects of clinical monitoring and site management
• Perform remote and on-site monitoring activities using a risk-based monitoring approach
• Conduct Source Data Review, Source Data Verification, and CRF review as applicable
• Assess investigational product accountability through inventory and records review
• Identify site process issues and implement corrective and preventive actions
• Identify, document, escalate, and follow through on site deficiencies and issues until resolution
• Maintain communication with investigational sites between monitoring visits
• Ensure trials follow approved protocols, ICH-GCP, applicable regulations, SOPs, and procedures
• Ensure essential study documents are complete, accurate, and maintained according to regulatory requirements
• Conduct on-site file reviews and support audit and inspection readiness
• Initiate clinical trial sites and support site close-out activities
• Participate in investigator meetings and support identification and assessment of potential investigational sites
• Respond to company, sponsor, and regulatory audit and inspection requirements
• Provide study status and progress updates to the Clinical Team Manager
• Maintain accurate and timely information in study systems, including CTMS
• Perform quality checks of CTMS-generated reports
• Facilitate communication between sites, sponsors, and project teams
• Contribute to project tools, communications, publications, process improvements, and best-practice sharing
• Support additional study activities such as trip report reviews, newsletters, or leading CRA team calls
• Participate in investigator payment processes
• Complete expense reports and timesheets accurately and on time

Requirements:

• Bachelor's degree in a life sciences-related field, Registered Nursing qualification, or equivalent relevant academic/vocational qualification
• At least 2+ years of experience as a Clinical Research Monitor / CRA, or comparable relevant experience
• Valid driver's license, where applicable
• Equivalent combinations of education, training, and directly related experience may also be considered
• Strong clinical monitoring and site management skills
• Excellent understanding and practical application of ICH-GCP, applicable regulations, and clinical research procedures
• Good knowledge of medical terminology and relevant therapeutic areas
• Experience applying Risk-Based Monitoring (RBM) principles and processes
• Strong critical thinking, root-cause analysis, and problem-solving capabilities
• Excellent attention to detail with strong organizational and time-management skills
• Effective written and verbal communication skills, including the ability to communicate confidently with medical professionals and investigational site staff
• Strong interpersonal skills and a collaborative, customer-focused approach
• Ability to adapt to changing priorities and work effectively both independently and as part of a global team
• Proficiency in Microsoft Office and the ability to quickly learn clinical trial systems and software
• Good written and spoken English
• Strong presentation skills
• Ability to travel frequently, typically 60–80%
• Ability to drive regularly to clinical trial sites
• Ability to undertake extended and overnight stays when required
• Compliance with applicable sponsor, client, and investigational site requirements

Benefits:

• The opportunity to work on innovative and diverse global clinical research programs
• Exposure to a broad range of sponsors, therapeutic areas, and clinical trial environments
• A collaborative and inclusive culture where your expertise and ideas are valued
• Continuous learning, professional development, and opportunities for career progression
• Competitive compensation and benefits
• Appropriate personal protective equipment provided or required for exposure to biological materials