Clinical Research Associate II

A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity.

You will be joining a program that takes an extensive co-monitoring approach, enabling a supportive and collaborative work environment. Frequent, consistent communication, both internally and with our client, positions our program to be closely aligned on our shared goals.

We are a comprehensive clinical research organization, powered by healthcare intelligence.

1. 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, providing instructions to site personnel, and study closeout.
2. Verify the protection of study participants by confirming informed consent procedures and protocol adherence in accordance with applicable regulations.
3. Ensure the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
4. Manage investigative site staff to facilitate trial deliverables, e.g., subject enrollment and data collection.
5. Verify proper management and accountability of Investigational Product (IP).
6. Write and submit reports of investigative site findings and update applicable tracking systems. Escalate observed deficiencies, issues, and corrective and preventative action plans as appropriate.
7. Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assist with resolution of investigational site/data queries.
8. Perform key risk assessment and management responsibilities throughout the project, including risk indicator and site health analysis, site process evaluation, and project escalation.
9. Participate in audit preparation and follow-up activities as needed.

Additional responsibilities include:

1. Performing a variety of onsite and offsite monitoring visits independently.
2. Gathering and reviewing information for assigned sites and identifying inconsistencies. Assess risk and escalate as appropriate with limited guidance.
3. Assisting with non-complex adhoc, short-term assignments in support of additional studies or departmental initiatives.
4. Potentially serving as preceptor, providing training to less experienced clinical team members.

• Hold an undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure (e.g., registered nurse).
• Have previous experience supporting clinical trials, including solid on-site monitoring experience.
• Willing to travel 50-80%.
• Equivalent combinations of education, training, and relevant experience may be considered. Fluency in English and host country language is required.

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

In addition to a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance for you and your family. Learn more at: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental. We are committed to providing an inclusive, accessible environment free of discrimination and harassment. Qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need a reasonable accommodation during the application or employment process, please let us know: https://careers.iconplc.com/reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply—perhaps you are exactly what we are looking for.