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Senior Clinical Research Associate – East Coast, NY/NJ
AstraZeneca. The Senior Clinical Research Associate (Sr.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant 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 reportsCTMS
Soft Skills
attention to detailwritten communicationverbal communicationcollaborationinterpersonal skillsnegotiation skills
Certifications
Bachelor's degree in life scienceequivalent qualification