Senior Clinical Research Associate

About the role

Alexion is hiring a Senior Clinical Research Associate (Sr. CRA) who takes local responsibility for the delivery of studies at allocated sites and is an active member of the local study teams. The Sr. CRA works closely with Project Management Clinical Operations, the Study Start-Up Manager, the Clinical Study Assistant and other CRAs to ensure study commitments are met on time and efficiently at country level, and acts as the main contact for the study site.

Key responsibilities

• Select, initiate, monitor and close out assigned sites in compliance with procedural documents, ICH-GCP and local regulations.
• Carry out selection, initiation, interim monitoring and closeout visits, remote data checks and remote monitoring in line with the study-specific Clinical Monitoring Plan.
• Drive site performance by identifying and resolving issues promptly and escalating them when needed.
• Train, support and advise investigators and site staff, including on Risk-Based Quality Management (RBQM).
• Develop recruitment plans, support enrolment and document recruitment barriers and mitigation plans.
• Monitor agreed monitoring KPIs such as action-item ageing, data-entry metrics, query ageing and MV report metrics.
• Prepare and finalise monitoring visit reports in the CTMS and provide timely feedback to the Principal Investigator.
• Ensure documents are collected and uploaded to the eTMF in line with ICH-GCP and SOPs, and support study start-up and regulatory maintenance, including submissions to the EC/IRB and regulatory authorities.
• Contribute to investigator nomination and feasibility activities, and escalate quality, data-privacy and ICH-GCP issues to the relevant groups.
• Prepare for and collaborate on audits and regulatory inspections.

Required profile

• Minimum of 4 years of CRA monitoring experience.
• Bachelor's degree in a related discipline, preferably life sciences, or equivalent.
• Good medical knowledge and understanding of the drug development process.
• Excellent attention to detail, written and verbal communication, collaboration and negotiation skills.
• Flexibility in scheduling and willingness to travel, which may be as high as 70% during busy periods; a valid driving licence where required locally.
• Preferred: experience across all study phases and in rare medical conditions.

Required skills

• ICH-GCP and local regulations
• Clinical study management, including monitoring, study drug handling and data management
• Remote collaboration and matrix reporting structures
• Use of CTMS and eTMF