The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites.
The Sr. CRA works in close collaboration with (Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs)
The Sr. CRA acts as the main contact with the study site and is responsible for monitoring study conduct.
Performing selection, initiation, interim monitoring and closeout visits (remote and onsite).
Proactively identifying and ensuring timely resolution to study-related issues.
Training, supporting and advising Investigators and site staff in study related matters.
Development of recruitment plans with each site and managing enrollment to ensure sites meet enrollment milestones.
Prepare and finalize monitoring visit reports in CTMS.

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, NY/NJ

Key skills