Senior CRA – Orthopedic Device Trials Lead

ICON Strategic Solutions; Chicago (IL); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Life assurance

Employee assistance program

Job summary

ICON Strategic Solutions in the United States seeks a Senior Clinical Research Associate (Orthopedic Device) to oversee monitoring activities across Dallas and Chicago. You will lead site visits, ensure protocol and GCP adherence, and train staff within a sponsor-dedicated model, supported by ICON’s global expertise.

The role emphasizes quality monitoring, cross-functional collaboration, and maintaining data integrity while traveling about 60% of the time, with some Canadian travel possible.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare field.
• 3–5 years of CRA monitoring experience in CRO/pharma.
• 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.
• Extensive CRA experience with regulatory requirements.
• Ability to manage multiple sites and projects simultaneously.
• Proficiency in monitoring practices, data integrity, and site management.
• Excellent communication and stakeholder management skills.
• Willingness to travel ~60%; limited Canadian travel may be required.

Responsibilities

• Lead on clinical trial monitoring tasks with a focus on quality and continuous improvement.
• Monitor sites to ensure adherence to study protocols, regulatory requirements, and GCP standards.
• Conduct site visits to assess site performance, resolve issues, and support trial execution.
• Collaborate with cross-functional teams for timely and accurate data collection and reporting.
• Provide training and guidance to site staff and other CRAs to maintain high standards.
• Build and maintain relationships with site personnel and stakeholders to facilitate smooth operations.

Skills

CRA monitoring

Regulatory compliance

GCP knowledge

Data integrity

Stakeholder management

Education

Bachelor's degree in a relevant field

Tools

Clinical trial software

Job description

ICON Strategic Solutions in the United States seeks a Senior Clinical Research Associate (Orthopedic Device) to oversee monitoring activities across Dallas and Chicago. You will lead site visits, ensure protocol and GCP adherence, and train staff within a sponsor-dedicated model, supported by ICON’s global expertise.

The role emphasizes quality monitoring, cross-functional collaboration, and maintaining data integrity while traveling about 60% of the time, with some Canadian travel possible.