Senior Clinical Research Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Senior Clinical Research Associate to support a study in the cardiovascular/electrophysiology medical device space, focusing on A-fib. The role involves monitoring and ensuring compliance with FDA regulations and ICH/GCP guidelines while maintaining effective communication with stakeholders.

Responsibilities

• To support 1study in the cardiovascular/electrophysiology medical device space
• The ideal candidate will have cardiovascular medical device monitoring experience- however, cardiovascular/electrophysiology pharma monitoring experience will be considered
• In-depth knowledge of FDA regulations and ICH/GCP guidelines
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment
• Ability to work independently and manage multiple priorities in a dynamic environment
• A well-executed plan for communication with the study teams and sites
• Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports
• Located in the US near a major airport. Ability to cover up to 65% regional travel

Preferred

• Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science
• Cardiovascular/electrophysiology pharma monitoring experience
• Bachelor's in Life Science
• Pharma Monitoring Experience

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Company

• Outsourced clinical development and commercialization services for life sciences
• Dublin , GB
• https://www.iconplc.com/services/strategic-solutions/
• 10001+ employees

Qualifications

• 3 Years Of Monitoring Experience Required
• In-depth knowledge of FDA regulations and ICH/GCP guidelines
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment
• Ability to work independently and manage multiple priorities in a dynamic environment
• A well-executed plan for communication with the study teams and sites
• Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports
• Located in the US near a major airport
• Ability to cover up to 65% regional travel
• Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science
• Cardiovascular/electrophysiology pharma monitoring experience

Required skills

• Cardiovascular medical device monitoring, Cardiovascular/electrophysiology pharma monitoring, Clinical trial management, FDA regulations knowledge, ICH/GCP guidelines knowledge, Multitasking, Report writing, Stakeholder communication

Preferred skills

• Independent work

Experience

• 3+ years