Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP)
Driving performance at the sites
Proactively identifying and ensuring timely resolution to study-related issues and escalate them as appropriate
Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles
Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones
Document recruitment barriers and mitigation plans
Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs
Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements

Minimum of 4 years of CRA monitoring experience
Bachelors degree in related discipline, preferably in life science, or equivalent qualification
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Excellent knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas
Good understanding of the drug development process
Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management
Excellent attention to detail
Excellent written and verbal communication skills
Excellent collaboration and interpersonal skills
Good negotiation skills
Valid driving license

Senior Clinical Research Associate – East Coast

Key skills