Senior CRA, Medical Device

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

Senior Clinical Research Associate - Orthopedic Device - Dallas / Chicago

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

What You Will Do

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement.

Key Responsibilities Include

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others.

Required Qualifications And Experience

• 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, with 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

What ICON Can Offer You

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• 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.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here