Single Sponsor CRA I/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, whether on-site or remotely.

• Ensure compliance with regulatory standards, ICH-GCP/GPP, and study protocols.

• Assess site and site staff performance, providing recommendations and action plans as necessary.

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

• Perform source document reviews and validate the accuracy and completeness of case report form data.

• Address queries both remotely and on-site, offering guidance to site staff.

• Confirm compliance with electronic data capture standards.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, and administration as needed.

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

• Document monitoring activities through necessary letters, reports, and communication logs.

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

• Monitor observations, site status, and track action items to resolution.

• Manage site-level activities and communications to align with project objectives, deliverables, and timelines.

• Serve as a liaison with study site personnel, ensuring compliance and training for site/project teams.

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

• Facilitate audit readiness and follow-up actions post-audit.

• For real-world late phase studies, support sites throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and recommend potential sites based on local knowledge.

⛳️ Requirements

• Proven experience in UK monitoring.

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

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Outstanding communication, presentation, and interpersonal abilities.

• Capacity to manage travel requirements of up to 75% on a regular basis.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Chance to collaborate with colleagues globally.