Senior CRA, Medical Device
Posted 22hrs ago
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Job Description
Senior CRA monitoring orthopedic medical-device trials for ICON’s sponsor-dedicated clinical research programs. Overseeing sites, compliance, data quality, and trial execution across U.S. locations.
Responsibilities:
- Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
- Lead clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement
- Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
- Conduct site visits to assess site performance, resolve issues, and support successful trial execution
- Collaborate with cross-functional teams on timely and accurate data collection and reporting
- Provide training and guidance to site staff and other CRAs
- Build and maintain relationships with site personnel and stakeholders to facilitate smooth trial operations
Requirements:
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- 3-5 years of CRA monitoring experience in CRO/pharma environments
- Strong CRA with experience managing complex protocols
- Medical device experience preferred but not required
- Orthopedic experience is a plus but not essential
- Experience in sports medicine, trauma, or related therapeutic areas would be beneficial
- Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
- Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
- Expertise in monitoring practices, data integrity, and site management
- Proficiency in relevant clinical trial software and tools
- Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
- Willingness to travel as required (approximately 60%)
- Limited Canadian travel may be required
- Legal right to work in the country where the role is based
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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