Senior Clinical Research Associate, Single Sponsor

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.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess the performance of sites and site staff, providing tailored recommendations and action plans.

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

• Perform reviews of source documents and validate the accuracy and completeness of CRF data.

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

• Ensure compliance with electronic data capture systems.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, administration, labeling, import, and return activities as necessary.

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

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

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

• Monitor observations, site status, and ensure action items are resolved.

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

• Serve as a liaison with project site personnel to ensure that assigned sites and site team members are adequately trained and compliant.

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

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

• Provide training and mentorship to junior CRAs and conduct training/sign-off visits as needed.

• Support study sites throughout their lifecycle, from identification to close-out.

• Conduct chart abstraction and data collection for real-world late-phase studies.

• Collaborate with sponsors, affiliates, medical science liaisons, and local country personnel.

• Identify activities that fall outside the project scope and propose potential sites, operational efficiencies, and process enhancements.

• Develop informed consent forms at the country level.

⛳️ Requirements

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

• Strong on-site monitoring experience in the UK, preferably gained from a CRO/Pharma setting.

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

• Exceptional communication, presentation, and interpersonal abilities.

• Foundational critical thinking skills.

• Willingness to travel as required, up to 30–50% regularly.

• Familiarity with ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

• Understanding of Good Pharmacoepidemiology Practice (GPP), where applicable.

🏝️ 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.

• Flexible remote work options.