Senior Clinical Research Associate - Medical Device

ICON; Texas; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning options

LifeWorks Employee Assistance Program

Job summary

ICON Strategic Solutions is seeking a Senior Clinical Research Associate to lead site monitoring for surgical device trials in the Central Region. The role emphasizes independent work, travel (~60%), and driving quality and compliance across sites.

You will monitor sites, conduct visits, and collaborate with cross-functional teams to ensure accurate data collection and timely reporting, while training site staff and building strong relationships with investigators and study teams.

Qualifications

• Bachelor’s degree in Life Science, Physical Science, Nursing or Biological Science.
• 3–5 years CRA monitoring experience in CRO/pharma environments.
• 1 year of medical device monitoring experience preferred.
• Strong knowledge of FDA regulations and ICH/GCP guidelines.
• Strong problem-solving and communication skills.
• Willingness to travel approximately 60%.

Responsibilities

• Monitor trial sites for protocol, regulatory and GCP compliance.
• Conduct site visits to assess performance and resolve issues.
• Collaborate with cross-functional teams for data collection and reporting.
• Provide training to site staff and other CRAs on trial conduct.
• Build and maintain relationships with site personnel and stakeholders.

Skills

CRA monitoring

FDA regulations

ICH/GCP guidelines

Interpersonal skills

Verbal communication

Written communication

Travel readiness

Education

Bachelor’s degree in Life Science

Job description

Senior Clinical Research Associate - Surgical Device - Central 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 of working independently and guide others. Required qualifications and experience:

• A bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
• 3-5 years of CRA monitoring experience in CRO/pharma environments
• Strong preference for at least 1 year of medical device monitoring experience- however, complex 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.
• Willingness to travel as required (approximately 60%)

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.

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

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.