Clinical Research Associate

About the Role

Our client is seeking a meticulous and experienced Clinical Research Associate (CRA) to join their dynamic clinical operations team based near Newcastle upon Tyne . You will play a crucial role in ensuring the successful execution of clinical trials by monitoring trial sites, ensuring compliance with protocols and regulations, and safeguarding patient data integrity. This position offers the chance to contribute to vital research in pharmaceutical development, working across a portfolio of innovative studies within a supportive and forward-thinking organisation.

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) guidelines.
• Verify the accuracy, completeness, and consistency of clinical data recorded in Case Report Forms (CRFs).
• Ensure adherence to study protocols, regulatory requirements, and ethical standards at all participating sites.
• Build and maintain strong relationships with investigators and site staff, providing guidance and support.
• Identify, document, and resolve site-level issues and deviations promptly.
• Prepare and present site monitoring reports, highlighting findings and action plans for improvement.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 2 years of experience as a Clinical Research Associate or equivalent.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent organizational, communication, and interpersonal skills.
• Ability to travel to clinical sites as required within the Newcastle upon Tyne region and potentially further afield.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health and wellness benefits package.
• Company car or travel allowance provided.
• Opportunities for career advancement and professional certifications.
• Flexible working arrangements, blending office and remote work to suit project needs.