ICON Strategic Solutions · 8 hours ago
Senior Clinical Research Associate - Orthopedics - Western US region
ICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Senior Clinical Research Associate to support 4-5 studies in Orthopedics, requiring monitoring experience with orthopedic medical devices or other medical devices/pharma. The role involves managing clinical trials and ensuring compliance with FDA regulations and ICH/GCP guidelines.
Pharmaceuticals
Responsibilities
Support 4-5 studies in various stages, Orthopedics
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
Qualification
Required
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
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 Western US region. Ability to do average 65% travel
Preferred
Orthopedic medical device monitoring experience- however, other device or pharma monitoring experience will be considered
Benefits
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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.