Senior Clinical Research Associate - Medical Device

ICON plc•Blue Bell, MO
•$110,520 - $138,150

About The Position

At ICON Strategic Solutions, the Senior Clinical Research Associate works in a sponsor-dedicated model, supported by ICON’s global expertise. The role leads clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. It involves monitoring and visiting clinical trial sites, supporting site staff, coordinating with cross-functional teams, and helping ensure trials are conducted in accordance with protocols, regulations, and Good Clinical Practice standards. The position is for the Central Region and requires approximately 60% travel.

Requirements

  • Bachelor’s degree required; preferably a Bachelor of Science in Life Science, Physical Science, Nursing, or Biological Science.
  • 3–5 years of CRA monitoring experience in CRO or pharmaceutical environments.
  • In-depth knowledge of FDA regulations and ICH/GCP guidelines.
  • Strong problem-solving skills to mitigate risks, identify site issues, 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, including the ability to communicate complex information clearly and concisely.
  • Ability to adapt communication style to the needs and preferences of different stakeholders and foster collaboration.
  • Ability to work independently and manage multiple priorities in a dynamic environment.
  • Ability to develop and execute a communication plan with study teams and sites.
  • Clinical trial management knowledge, with rigorous attention to detail and precision in reports.
  • Willingness to travel as required, approximately 60%.
  • Legal right to work in the country where the role is based.

Nice To Haves

  • At least 1 year of medical device monitoring experience is strongly preferred; complex pharmaceutical monitoring experience will also be considered.

Responsibilities

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

Benefits

  • Competitive base salary and performance-related incentives.
  • 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.
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