Clinical Research Associate

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

📋 Description

• Carry out clinical monitoring tasks at clinical trial sites in compliance with ICH guidelines, GCP, local regulations, and SOPs

• Conduct feasibility assessments, site identification, selection, and evaluation

• Prepare and assist with site lists and recruitment objectives

• Deliver protocol and study training to designated sites

• Perform pre-study, initiation, routine monitoring, and closeout visits

• Undertake co-monitoring visits as necessary

• Complete monitoring visit reports following ICH-GCP, BeOne standards, and SOPs

• Oversee site performance by tracking regulatory submissions, recruitment, CRF completion, and resolving data queries

• Establish communication with sites and report on progress, issues, and recommended actions to Clinical Operations

• Ensure studies and sites are inspection-ready

• Collaborate with the Regional Clinical Operations Manager and sites to achieve study milestones

• Facilitate Study Oversight Visits, site audits, and inspections as needed

• Assess site practice quality and integrity, escalating any quality or GCP concerns

• Identify site challenges, suggest corrective and preventive measures, and pinpoint improvement opportunities

• Encourage operational excellence, innovation, and continuous improvement

⛳️ Requirements

• Preferably 2–5 years of CRA monitoring experience within the pharmaceutical or CRO sector

• Exceptional communication and interpersonal abilities

• Strong organizational skills with the capacity to prioritize and manage multiple tasks

• Proficient in English, both written and spoken

• Skilled in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook

• Comprehensive understanding of clinical trial processes, ICH guidelines, and relevant regulatory standards

🏝️ Benefits

• Equal opportunity employment

• Travel up to 60%