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.
What you will be doing:
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 according to 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, such as subject enrollment and data submission.
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 deficiencies, issues, and corrective actions as appropriate.
7. Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after the study; assist with resolving site/data queries.
8. Perform key risk assessments and management responsibilities, including site health analysis, process evaluation, and project escalation.
9. Participate in audit preparation and follow-up activities as needed.
10. Perform various onsite and offsite monitoring visits independently.
11. Gather and review information for assigned sites, identify inconsistencies, assess risks, and escalate as needed.
12. Assist with non-complex adhoc or short-term assignments supporting additional studies or initiatives.
13. Potentially serve as a preceptor, providing training to less experienced team members.
You are:
* Hold an undergraduate degree or equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure such as registered nurse is also acceptable.
* Have previous experience supporting clinical trials, including solid on-site monitoring experience.
* Willing to travel 50-80%.
* Equivalent education, training, and relevant experience may be considered in lieu of formal education. Fluency in English and the host country language is required.
What ICON can offer you:
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 benefits focused on well-being and work-life balance for you and your family. Learn more at our benefits page.
ICON values inclusion and belonging, providing an environment free of discrimination and harassment. We encourage all qualified applicants to apply, regardless of whether they meet every requirement.
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