Senior CRA role at ICON. Lead complex site management, mentor junior CRAs & ensure GCP compliance. 5+ yrs monitoring exp & 60% travel required. Strategic field-based position.
Lead with Expertise: Be the Strategic Site Leader for Complex Clinical Trials
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life.
We are seeking an accomplished and independent Senior Clinical Research Associate (SCRA) to take on a leadership role within our monitoring team. In this high-impact field-based position, you will be entrusted with the most complex and strategic investigative sites. You will serve as a subject matter expert, a mentor to junior colleagues, and the primary guardian of data quality and regulatory compliance. Your seasoned judgment and advanced site management skills will be critical to the success of our most challenging clinical trials.
Your Mission: Strategic Oversight, Mentorship, and Uncompromising Quality
As a Senior CRA, you are more than a monitor; you are a site strategist and a team leader. You will proactively manage site performance, drive issue resolution at a senior level, and elevate the standards of clinical trial conduct within your portfolio and beyond.
Key Responsibilities
1. Advanced Site Management & Strategic Oversight
- Serve as the primary lead for complex, high-enrolling, or high-risk sites, conducting all types of monitoring visits (SQV, SIV, RMV, COV) with a focus on strategic issue anticipation and resolution.
- Perform in-depth data review and source data verification (SDV), applying expert judgment to identify trends, assess risks, and ensure data integrity.
- Proactively manage site performance, including patient recruitment strategy, data quality, and protocol compliance, acting as a strategic partner to Principal Investigators.
2. Mentorship & Team Leadership
- Provide coaching, guidance, and training to site staff and junior/less experienced CRAs, fostering a culture of quality and compliance.
- Act as a subject matter expert (SME) within the study team, contributing to monitoring plans, risk-based strategies, and process improvements.
- May assist in the co-monitoring and assessment of new CRA hires.
3. Cross-Functional Collaboration & Compliance Leadership
- Collaborate seamlessly with cross-functional teams (Clinical Trial Management, Data Management, Safety) to ensure timely data flow, query resolution, and holistic site management.
- Build and maintain senior-level relationships with key opinion leaders (KOLs) and site personnel to facilitate optimal trial execution.
- Ensure all site activities are conducted in full compliance with ICH-GCP, applicable local regulations, and ICON SOPs.
- Represent monitoring during audits and regulatory inspections as required.
Who You Are: The Ideal Strategic Partner
You are a seasoned, diplomatic, and results-driven professional who operates with a high degree of autonomy. You are a natural leader who derives satisfaction from mentoring others and solving complex, strategic challenges at the site level.
Your Required Profile:
- Bachelor’s or advanced degree in Life Sciences, Nursing, Medicine, or a related field.
- Minimum of 5+ years of experience as a Clinical Research Associate, with a proven track record of independent site management across all visit types.
- Extensive knowledge of ICH-GCP guidelines and major regulatory agency requirements.
- Proven expertise in monitoring practices, data integrity assurance, and the use of clinical trial software (EDC, CTMS, TMF).
- Exceptional organizational, problem-solving, and leadership skills.
- Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance.
- Ability and willingness to travel approximately 60% (domestic/international). A valid driver’s license is required.
What Sets You Apart (Preferred):
- Experience in specific therapeutic areas (e.g., Oncology, Cell & Gene Therapy, CNS).
- Formal experience in mentoring or training other CRAs.
- Experience with Risk-Based Monitoring (RBM) methodologies.
- Professional certification (e.g., CCRA, SoCRA).
Why Advance Your Career as a Senior CRA at ICON?
1. Recognized Expertise & Autonomy
- Manage a portfolio of strategic sites with a high level of trust and independence.
- Be recognized as a go-to expert and internal leader within the monitoring function.
2. Clear Pathway to Leadership
- This role is a direct stepping stone to Lead CRA, Clinical Trial Manager (CTM), or Site Management leadership positions.
- Play a key role in shaping monitoring quality and best practices across the organization.
3. Comprehensive Senior Field Package
- Highly competitive salary and significant performance-based bonus potential.
- Comprehensive travel package, including car allowance and full expense coverage.
- Generous annual leave entitlements.
- Premium health, life, and disability insurance for you and your family.
- Global Employee Assistance Programme and dedicated career development support.
Join a Culture that Values Senior Expertise
At ICON, we believe that experienced professionals are the cornerstone of clinical excellence. We are committed to creating an inclusive environment and encourage all qualified senior candidates to apply.
Ready to leverage your expertise to lead sites, mentor colleagues, and drive clinical trial success?
If you are a strategic site leader passionate about quality and mentorship, we want to hear from you. Apply now.
