Ensure Excellence at the Source: Clinical Research Associate II (CRA II)
At ICON, the integrity of every data point and the safety of every patient begins at the clinical site. As a Clinical Research Associate II, you are not just a monitor—you are the essential link between our research protocols and the real world. Your expertise, vigilance, and relationship-building skills ensure that every trial is conducted with uncompromising scientific and ethical rigor.
We are looking for an experienced and independent CRA to take ownership of the complete site management lifecycle. If you are driven by meticulous attention to detail, excel at proactive problem-solving, and are passionate about upholding the highest standards in clinical research, this role is your opportunity to directly advance new therapies and grow your career with a global leader.
Your Mission: Be the Guardian of Protocol Integrity
Lead End-to-End Site Oversight
- Conduct the full spectrum of site visits—qualification, initiation, routine monitoring, and close-out—ensuring strict adherence to study protocols, ICH-GCP guidelines, and all regulatory requirements.
- Serve as the primary point of contact for your assigned investigative sites, building strong, collaborative partnerships with investigators and site staff to foster smooth study conduct and rapid issue resolution.
Champion Data Integrity & Patient Safety
- Perform rigorous source data verification (SDV) and meticulous review of case report forms (eCRFs/CRFs) to guarantee the accuracy, completeness, and consistency of every clinical data point.
- Act as a vigilant protector of patient safety and rights, verifying that all site activities strictly follow the approved protocol and ethical standards.
- Proactively identify, document, and resolve site issues, deviations, or compliance gaps, implementing timely and effective corrective actions.
Uphold Documentation and Process Excellence
- Contribute to the preparation and review of critical study documentation, including protocols, clinical study reports (CSRs), and monitoring visit reports.
- Ensure all essential regulatory documents are collected, reviewed, and maintained to keep the Trial Master File (TMF) in a constant state of audit and inspection readiness.
- Support sites with regulatory and safety reporting obligations, including the management of Serious Adverse Event (SAE) reporting.
Who You Are
You are a proactive professional who understands that your critical eye and collaborative approach directly impact patient safety and the success of pioneering research.
Your Foundation
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related healthcare/scientific field.
- Minimum of 2 years of independent, on-site Clinical Research Associate (CRA) monitoring experience within a CRO, pharmaceutical, or biotechnology environment.
- In-depth, practical knowledge of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements.
- Ability to travel approximately 60% of the time (domestic and international) and possession of a valid driver’s license.
Your Core Strengths
- Independent & Detail-Oriented: You manage multiple sites and priorities with exceptional organization and an unwavering focus on quality.
- Exceptional Communicator: You build trust, influence effectively, and resolve issues with clarity, professionalism, and tact.
- Proactive Problem-Solver: You anticipate risks, diagnose root causes, and implement practical solutions to keep studies on track.
- Collaborative Team Player: You are a reliable partner who works seamlessly within cross-functional local and global teams.
Why Build Your Monitoring Career at ICON?
Impact Global Drug Development
Your work ensures the integrity of data that forms the foundation for regulatory approvals, directly helping to bring new treatments to patients faster.
Grow Your Expertise
- Clear career progression to Senior CRA, Lead CRA, and Clinical Team Lead roles.
- Exposure to a diverse portfolio of studies across multiple therapeutic areas and phases.
- Continuous professional development through structured global training and mentorship.
Be Part of a Supportive, Inclusive Culture
Join a diverse and dynamic team where inclusion, belonging, and innovation are core to our values. We offer comprehensive support, robust processes, and a collaborative international network.
Competitive ICON Benefits
We provide an attractive salary and performance-based incentives, comprehensive health and retirement benefits, generous paid time off, a travel allowance, and ongoing investment in your professional growth.
Ready to Be the Trusted Expert at Our Clinical Sites?
If you are a dedicated, travel-ready CRA passionate about upholding the highest standards in clinical research, we encourage you to apply.
Apply now to become the guardian of excellence who ensures every trial is conducted with precision, integrity, and care.
