Senior Clinical Research Associate

ICON plc • Chicago, MO

1d • Hybrid

About The Position

The Senior Clinical Research Associate (Senior CRA) plays a critical role in data integrity, patient safety, and overall quality of clinical trials conducted at investigative sites. The Senior CRA independently monitors trials either onsite or remotely, ensuring compliance with protocols, ICH-GCP guidelines, ICON and/or customer SOPs, and applicable regulatory requirements. The Senior CRA supports complex studies, contributes to operational excellence, and serves as a mentor to junior staff, while maintaining site readiness for audits and inspections.

Requirements

• Bachelor’s degree required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
• 3 years of monitoring required (medical device, pharma, CRO industry).
• 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.
• Rigorous, detail-oriented, and precise in their reports.

Nice To Haves

• Medical device monitoring experience.
• Pharma monitoring experience will be considered.
• Neuro or Neurovascular monitoring experience a plus.

Responsibilities

• Independently monitors trials either onsite or remotely, ensuring compliance with protocols, ICH-GCP guidelines, ICON and/or customer SOPs, and applicable regulatory requirements.
• Supports complex studies.
• Contributes to operational excellence.
• Serves as a mentor to junior staff.
• Maintains site readiness for audits and inspections.

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior