Clinical Research Associate II, UK Monitoring Experience

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits, either on-site or remotely.

• Assess the performance of sites and site staff, providing recommendations and actionable plans.

• Confirm informed consent, uphold subject confidentiality, ensure safety, and maintain clinical data integrity.

• Evaluate site processes and perform source document reviews.

• Validate the accuracy and completeness of clinical data in case report forms.

• Address queries both remotely and on-site within established timelines.

• Assist in the review of clinical study data, ensuring compliance with electronic data capture standards.

• Conduct inventory, reconciliation, and storage reviews of investigational products as required.

• Review Investigator Site Files and ensure they align with Trial Master Files.

• Record monitoring activities and maintain tracking systems.

• Aid in strategies for subject/patient recruitment, retention, and awareness.

• Oversee site-level activities, communications, deliverables, and timelines.

• Collaborate with study site personnel to ensure training and compliance of the site/project team.

• Participate in investigator, sponsor, monitoring, and clinical training meetings.

• Contribute to audit readiness and follow-up actions post-audit.

• For real-world late-phase studies, support sites throughout their lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, provide training to junior staff as needed, and identify activities outside the project scope and potential sites.

⛳️ Requirements

• Required UK monitoring experience.

• A Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Understanding of Good Clinical Practice/ICH Guidelines and other relevant regulatory standards.

• Proficient computer skills with an eagerness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Capacity to manage necessary travel, which may be up to 75% regularly.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive company culture.

• Remote work arrangement (Remote (Pre-Approved)).