Senior Clinical Research Associate – East Coast, FL/GA
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Atlanta • Florida • United States
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Job Level
Tech Stack
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CRA monitoring experienceClinical Study Managementstudy drug handlingdata managementrecruitment plans developmentmonitoring visit reports preparationQC checks of eTMFKPI monitoring
Soft Skills
attention to detailwritten communicationverbal communicationcollaborationinterpersonal skillsnegotiation skillsflexibilitywillingness to travel