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Senior Clinical Research Associate
Alira HealthSenior Clinical Research Associate overseeing site monitoring activities for clinical trials at Alira Health. Ensuring compliance and quality in collaboration with project teams.
About the role
Key responsibilities & impact- Conduct site monitoring responsibilities for clinical trials
- Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality
- Ensure appropriate and timely investigator site visits
- Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements
- Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed
- Prepare consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
- Participate in internal, client/sponsor, scientific, and other meetings as required
Requirements
What you’ll need- US: BS/BA from an undergraduate program (life sciences or related discipline preferred)
- US: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience with 1 year of management experience
- EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and ability to autonomously manage monitoring activities
- Strong command of English, both written and verbal
- Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
- Permanent authorization to work in the U.S.
- Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.
Benefits
Comp & perks- professional development
- global travel
- flexible work programs
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
clinical monitoringsite monitoringprotocol deviationsstudy progress trackingenrollment status reportingco-monitoringevaluation visitsSOP adherencebudget managementinvestigator site visits
Soft Skills
leadershipguidanceoversightcommunicationfeedbackorganizational skillsproblem-solvingteam collaborationtime managementattention to detail
Certifications
Certified MonitorBS/BA in life sciences or related discipline