Senior Clinical Research Associate managing local study delivery and site monitoring for clinical studies. Collaborating with various stakeholders in accordance with clinical guidelines and local regulations.
Responsibilities
Performing selection, initiation, interim monitoring and closeout visits (remote and onsite)
Driving performance at the sites
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 and supporting enrollment
Ensuring agreed monitoring KPIs are observed
Preparing and finalizing monitoring visit reports in CTMS
Supporting/participating in regular QC checks of the eTMF
Contributing to the nomination and selection of potential investigators
Preparing for and collaborating with the activities associated with audits and regulatory inspections
Requirements
Minimum of 4 years of CRA monitoring experience
Bachelor's degree in related discipline, preferably in life sciences, or equivalent qualification
Excellent knowledge of international guidelines ICH-GCP
Excellent knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas
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.
Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)
Benefits
Health insurance
Retirement plans
Professional development
Job title
Senior Clinical Research Associate – East Coast, FL/GA
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