Senior Clinical Research Associate

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

📋 Description

• Oversee the preparation, initiation, routine monitoring, and closeout phases of assigned clinical trial sites.

• Act as the primary liaison for investigative sites, assisting with patient recruitment objectives.

• Educate, support, and guide investigators and site staff on study requirements, protocol implementation, and Risk-Based Quality Management.

• Perform both onsite and remote monitoring visits, including source data review, verification, and case report form examination.

• Detect, manage, and escalate site and study issues for prompt resolution.

• Conduct site quality risk assessments and modify monitoring activities throughout the study's duration.

• Guarantee timely reporting of serious adverse events, resolution of queries, and quality data collection.

• Keep study information updated in the CTMS and other clinical systems.

• Assist in the collection, review, uploading, and maintenance of essential documents in the eTMF and investigator site files.

• Collaborate with local study teams, quality colleagues, and stakeholders during audits, inspections, and overall study delivery.

• Manage study supplies, drug accountability, and associated documentation.

• Provide insights into site performance, investigator engagement, and local research environments.

⛳️ Requirements

• Located in the UK, preferably in the South West of England, or willing to travel there frequently.

• Strong skills in site management, clinical monitoring, and stakeholder engagement.

• Experience in clinical research and regulated settings.

• Ability to collaborate effectively across cross-functional teams and communicate confidently with investigators and site personnel.

• Patient-centered mindset with a dedication to quality, compliance, and operational excellence.

• Comfortable using CTMS, eTMF, remote monitoring tools, and other clinical trial systems.

• Excellent organizational skills with the capability to handle multiple priorities and timelines.

• Proactive in problem-solving and committed to continuous improvement.

• Bachelor’s degree in a life science or a related field, or equivalent experience that meets local market requirements.

• Substantial clinical research experience with proven expertise in site monitoring and execution of clinical trials.

• Strong knowledge of ICH GCP and familiarity with applicable local regulatory standards.

• Good understanding of clinical study management, drug handling, data management, and clinical trial processes.

• Experience with CTMS, eTMF, and other clinical research technologies and systems.

• Strong written and verbal communication, organizational, and problem-solving abilities.

• Proficiency in both written and spoken English.

• Willingness to travel nationally and internationally as required.

• Valid driving license in accordance with local country regulations, where applicable.

• Preferred: experience in supporting global clinical studies within pharmaceutical or biotechnology sectors.

• Preferred: knowledge of risk-based monitoring and remote monitoring techniques.

• Preferred: CRA/Senior CRA experience in Oncology clinical trials.

• Preferred: experience in supporting regulatory inspections and audit preparedness.

• Preferred: strong cultural awareness and experience in global team collaboration.

• Preferred: proven ability to identify efficiencies and contribute to high-quality clinical trial outcomes.

🏝️ Benefits

• Health, Vision & Dental Insurance

• Vacation/Holiday/Sick Time

• Flexible benefit portal

• Car or car allowance (only applicable for certain roles)

• Flexibility and opportunities for growth