Senior CRA II – Single Sponsor, UK Monitoring

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

📋 Description

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

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and protocol compliance.

• Assess the performance of sites and site staff, recommending actions tailored to specific sites.

• Identify serious issues and formulate action plans for resolution.

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

• Evaluate site processes and perform source document reviews.

• Validate clinical data in case report forms against source documents and medical records.

• Address queries remotely and on-site within established timeframes.

• Utilize hardware and software for reviewing and capturing clinical study data.

• Ensure compliance with electronic data capture systems.

• Conduct reviews of investigational product inventory, reconciliation, storage, dispensing, and administration as necessary.

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

• Record monitoring activities in the 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 goals, deliverables, and timelines.

• Serve as a liaison with study site personnel, ensuring adequate training and compliance for the site team.

• Prepare for and participate in investigator and sponsor meetings.

• Engage in or lead clinical monitoring/project staff meetings and attend clinical training sessions.

• Aid in maintaining audit readiness and follow-up actions post-audit.

• Provide guidance, training, and mentorship to junior CRAs.

• Conduct training and sign-off visits for junior CRA personnel.

• Potentially participate in business development proposals and defense meetings.

⛳️ Requirements

• A 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.

• Strong computer skills and a willingness to adapt to new technologies are essential.

• Exceptional communication, presentation, and interpersonal skills are required.

• Moderate critical thinking skills are necessary.

• Ability to manage regular travel requirements of up to 75%.

• Substantial experience in UK monitoring is a must.

🏝️ 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.

• Emphasis on a Total Self culture.

• Initiatives promoting diversity, inclusion, and a sense of belonging.