Where Empathy Meets Science to Accelerate Life Sciences Research
Clinical Research Associate
Location
Massachusetts
Posted
7 days ago
Salary
$85K - $125K / year
Seniority
Mid Level
Job Description
Clinical Research Associate
Alira Health
• Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. • Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. • Ensures appropriate and timely investigator site visits. • Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. • Assists in development of study-specific Monitoring Plans and training presentations as required. • Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. • Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
Job Requirements
- Graduation in a scientific health field
- Certified Monitor in compliance with Italian CRO decree dated 15Nov2011
- Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
- Ability to autonomously manage monitoring activities
- Quality focused; Proven ability to be careful, thorough, and detail-oriented
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Ability to travel
- Knowledge of clinical research, ICH GCP and local regulations
- Knowledge of Regulatory and Ethical requirements
Benefits
- Professional development
- Global travel
- Flexible work programs
- Creative environment
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