Senior Clinical Research Associate

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

📋 Description

• Ensure adherence to study protocols, ICH-GCP guidelines, regulatory standards, and company procedures at designated sites.

• Assess site performance and suggest tailored actions, escalating critical issues and aiding in the development of corrective action plans.

• Confirm that informed consent processes are executed and documented correctly.

• Evaluate patient safety and the integrity of clinical data by detecting protocol deviations, violations, pharmacovigilance issues, and site-specific risks.

• Perform both remote and on-site monitoring in line with the Clinical Monitoring Plan and Study Monitoring Plan.

• Conduct source document reviews and verifications to guarantee that clinical data is precise, comprehensive, and substantiated by source documentation.

• Oversee protocol deviation reporting, follow-up actions, and the resolution of data inquiries.

• Review investigational product accountability, storage, security, dispensing, administration, reconciliation, and associated documentation.

• Record monitoring findings and study activities through monitoring reports, follow-up letters, communication logs, and other necessary documentation.

• Ensure that study activities are executed by suitably trained and assigned site personnel.

• Maintain a record of observations, action items, site status, and study progress in required systems and tools.

• Evaluate site documentation, training compliance, delegation logs, enrollment logs, accountability records, and essential study documents for readiness for inspection.

• Engage in meetings with investigators, sponsors, monitors, and project teams.

• Collaborate with the primary Site Manager and stakeholders to achieve study objectives, deliverables, and timelines.

⛳️ Requirements

• Bachelor’s degree, Registered Nurse (RN), or a comparable mix of education, training, and experience.

• Background in clinical research monitoring, specifically with oncology trial experience and familiarity with RECIST criteria.

• Understanding of ICH-GCP, relevant regulatory requirements, and clinical trial processes.

• Experience in performing both on-site and remote monitoring activities.

• Excellent verbal and written communication, presentation, organizational, and interpersonal skills.

• Capability to establish and sustain effective relationships with investigator site personnel and study stakeholders.

• Proficiency in the local language.

• Advanced or fluent English language skills.

• Experience in clinical research and regulated environments.

• Comfort in utilizing clinical trial systems, monitoring processes, and adapting to new technologies.

• Ability to adjust to shifting priorities while keeping focus on study objectives and timelines.

🏝️ Benefits

• Remote/home-based position.

• Opportunities for continuous learning and professional growth.

• Flexible working environment.

• Growth-oriented atmosphere.

• Chance to contribute to innovative therapies and make a meaningful impact on patients.