Senior Clinical Research Associate

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

Benefits offered by this job

Competitive base salary

Health and wellbeing programs

Retirement and pension plans

Learning and development opportunities

Job summary

ICON Strategic Solutions seeks a Senior Clinical Research Associate for Cardio (Smartpulse A-fib) to monitor cardiovascular medical device trials and support regulatory compliance. Based in the US West region, candidates should be able to travel up to 65% and collaborate with sites, investigators, and internal teams.

The role requires a bachelor’s degree and at least 3 years of monitoring experience, with preference for life science backgrounds.

Qualifications

• 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.
• Well-versed in clinical trial management with rigorous, detailed reporting.

Responsibilities

• Monitor cardiovascular medical device trials in the sponsor-dedicated model.
• Coordinate with sites, investigators, and internal teams to ensure trial progress.
• Ensure regulatory compliance with FDA/ICH guidelines.
• Communicate study updates clearly to all stakeholders and teams.
• Travel coverage up to 65% across the West region of the US.

Skills

FDA regulations

ICH/GCP guidelines

problem solving

interpersonal skills

communication skills

stakeholder communication

independence

multitasking

trial management

Education

Bachelor’s degree

Job description

Senior Clinical Research Associate - Cardio (Smartpulse A-fib) - All Regions

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.

To support 1study in the cardiovascular/electrophysiology medical device space. Indication is A-fib.

• The ideal candidate will have cardiovascular medical device monitoring experience- however, complex experience in cardiovascular/electrophysiology pharma monitoring and/or Coordinator/Nursing experience will be considered.

3 years of monitoring experience required.

A bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.

Candidates must have/ be:

• 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.
• Located in the West region in the US near a major airport. Ability to cover up to 65% regional travel.

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