Senior Clinical Research Associate, Medical Device

Regulatory Toolkit; United States; Remote; USD 111,000 - 138,000; Full time

Benefits offered by this job

Competitive base salary

Health and wellbeing programmes

Retirement plans

Life assurance

Employee assistance programmes

Learning and development opportunities

Job summary

ICON Strategic Solutions, sponsor-dedicated unit of ICON, seeks a Senior Clinical Research Associate for orthopedic devices covering the Midwest/West region. You will monitor trials, ensure GCP compliance, and support site performance to drive quality data and patient safety.

Ideal candidates have 3–5 years of CRA monitoring experience in CRO/pharma, a Bachelor’s in a scientific field, and strong communication.

Qualifications

• 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 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 regulatory knowledge.
• Willingness to travel approximately 60% (limited Canadian travel).

Responsibilities

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

Skills

CRA monitoring

Complex protocols

GCP compliance

Data integrity

Site management

Stakeholder management

Communication skills

Travel willingness

Orthopedic experience

Sports medicine

Education

Bachelor's degree in a relevant scientific discipline or healthcare-related field

Tools

Clinical trial software

Job description

Senior Clinical Research Associate - Orthopedic Device - Midwest/West Region

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.

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Salary Range

$110,520.00-$138,150.00