Clinical Research Associate (CRA)

About the role

Alexion is hiring a Clinical Research Associate (CRA) who takes local responsibility for the delivery of studies at their assigned sites and is an active member of the local study teams. The CRA works closely with Project Management Clinical Operations, the Study Start-Up manager, the Clinical Study Assistant and other CRAs to achieve study commitments on time and efficiently, and acts as the main contact with the study site. The role covers site identification, selection, initiation, monitoring and closeout in line with ICH-GCP and local regulations.

Key responsibilities

• Carry out site identification, selection, initiation, monitoring, data review and closeout visits (remote and onsite), and remote data checks, following the study-specific Clinical Monitoring Plan
• Drive site performance, resolve study issues proactively and escalate them when appropriate
• Train, support and advise Investigators and site staff, including on Risk-Based Quality Management (RBQM)
• Develop recruitment plans with each site, support enrollment and document recruitment barriers
• Ensure monitoring KPIs stay within agreed quality ranges (action items, SDV, data entry, query aging, MV reports)
• Prepare and finalize monitoring visit reports in CTMS and give feedback to the Principal Investigator
• Ensure documents are uploaded to the eTMF on time and take part in eTMF quality checks
• In some countries, handle study start-up and regulatory maintenance, including applications to EC/IRB and regulatory authorities
• Contribute to investigator nomination and feasibility, and escalate quality, data privacy and ICH-GCP issues to the Global Study team and Quality Group
• Prepare for audits and regulatory inspections

Required profile

• Minimum of 1 year of CRA monitoring experience
• Bachelor's degree in a related discipline, preferably life sciences, or equivalent
• Excellent written and verbal communication in English and the local language
• Willingness to travel, which may be as high as 70% during busy periods
• Ability to work with remote collaborators and in a matrix reporting structure
• 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
• Good medical knowledge and understanding of the drug development process
• Attention to detail, negotiation and collaboration skills
• Preferred: GCP or work-related certification