Senior CRAII/Sr CRA - Multi-sponsor

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

📋 Description

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

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

• Assess the performance of sites and site personnel, offering recommendations and action plans.

• Report serious issues to the project team for escalation.

• Verify the informed consent process, maintain subject/patient confidentiality, and ensure the safety and integrity of clinical data.

• Evaluate site processes and perform source document reviews.

• Confirm the accuracy of clinical data in case report forms and manage query resolutions.

• Utilize hardware and software for the review and capture of clinical study data.

• Ensure compliance with electronic data capture protocols.

• Conduct inventory, reconciliation, and security reviews of investigational products when necessary.

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

• Document monitoring activities using necessary project documentation and tracking systems.

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

• Oversee site-level activities and communications to achieve project objectives, deliverables, and timelines.

• Serve as the primary point of contact with study site personnel or collaborate with the Central Monitoring Associate.

• Ensure training and compliance of assigned sites and project-specific team members.

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

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

• Stay informed on applicable guidelines, regulations, and company SOPs, completing all required training.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or a comparable combination of education, training, and experience.

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

• Prior monitoring experience in the UK is essential.

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

• Exceptional communication, presentation, and interpersonal abilities.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive rewards program.

• Inclusive workplace culture.

• Reasonable accommodations provided when necessary.