Clinical Research Associate (Northeast)

ICON; United States; Remote; USD 60,000 - 80,000; Full time

Job description

As a CRA II, you will join the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.

What you will be doing:

• Complete onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, and providing instructions to site personnel and study close-out.
• Verify the protection of study participants by confirming informed consent procedures and protocol adherence according to applicable regulations.
• Ensure the integrity of clinical data and that the study complies with the approved protocol, GCP, applicable regulations, and SOPs.
• Manage investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data submission.
• Verify proper management and accountability of Investigational Product (IP).
• Write and submit reports of investigational site findings and update relevant tracking systems. Escalate deficiencies, issues, and corrective/preventive actions as needed.
• Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assist with resolving investigational site/data queries.
• Perform key risk assessments and management tasks throughout the project, including risk indicator and site health analysis, site process evaluation, and project escalation.
• Participate in audit preparation and follow-up activities as needed.
• Perform various onsite and offsite monitoring visits independently.
• Gather and review information for assigned sites, identify inconsistencies, assess risk, and escalate appropriately with limited guidance.
• Assist with non-complex ad hoc, short-term assignments to support additional studies or departmental initiatives.
• Potentially serve as a preceptor, providing training to less experienced team members.

You are:

• At least 2 years of experience supporting clinical trials, including 2 years of on-site monitoring experience.
• Deep understanding of the drug development process.
• In-depth knowledge and practical application of ICH-GCP and relevant regulatory requirements.
• Familiar with applicable policies, SOPs, work instructions, and guidance documents.
• Excellent communication, presentation, interpersonal, collaboration, and time management skills.
• Proficient with Microsoft Office and clinical systems.
• Strong critical thinking and organizational skills.
• Detail-oriented with high accuracy.
• Willing and able to travel extensively.
• Capable of establishing effective relationships with investigative site staff.
• Hold an undergraduate degree or equivalent in clinical, science, or health-related fields; health care professional licensure (e.g., registered nurse). An equivalent combination of education, training, and experience may be considered. Fluency in English and host country language is required.

What ICON can offer you:

Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

Along with a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme (TELUS Health)
• Life assurance
• Flexible, country-specific benefits such as childcare vouchers, gym discounts, travel passes, and health assessments

Visit our careers website for more: https://careers.iconplc.com/benefits

ICON values inclusion & belonging. We are committed to providing an accessible, discrimination-free environment. If accommodations are needed during the application process, please inform us via the provided link: https://careers.iconplc.com/reasonable-accommodations

We encourage you to apply even if you don't meet all requirements—your skills may still be a perfect fit for this or other roles at ICON.