Single Sponsor 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, recommending specific actions as needed.

• Escalate critical issues and formulate action plans to address them.

• Ensure informed consent is obtained, uphold subject confidentiality, and maintain the integrity of clinical data and safety.

• Evaluate site processes and perform reviews of source documents.

• Validate clinical data in case report forms and resolve any queries.

• Ensure compliance with electronic data capture protocols.

• Manage the inventory, reconciliation, storage, dispensing, and administration of investigational products as necessary.

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

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

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

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

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

• Collaborate with study site personnel and Central Monitoring Associates.

• Provide training to assigned sites and project-specific team members.

• Prepare for and participate in Investigator Meetings, sponsor meetings, project meetings, and clinical training sessions.

• Assist in maintaining audit readiness and follow-up actions after audits.

• In the context of Real World Late Phase studies, support sites throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsor affiliates, medical science liaisons, and local country staff, train junior team members, identify out-of-scope activities, and recommend potential sites.

⛳️ Requirements

• 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 standards.

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

• Exceptional communication, presentation, and interpersonal abilities.

• Capability to manage travel requirements of up to 30-40% regularly.

• Must possess experience in UK monitoring.

• Must reside in the UK.

• Must adhere to applicable site requests for medical and personal information as required for facility access.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations, when appropriate, for employees or applicants with disabilities.