⚡ Accelerate Clinical Trial Site Activation as an SSU Expert
Join ICON plc as a Senior Site Start-Up CRA and leverage your extensive clinical research expertise to drive rapid and compliant site activation. In this specialized senior role, you'll focus on the critical start-up phase, ensuring sites are qualified, initiated, and ready for successful trial execution while mentoring junior team members and leading start-up excellence.
🎯 Your Impact: Key Responsibilities
Site Start-Up Leadership
- Lead site qualification and initiation activities with strategic oversight
- Manage site activation timelines and mitigate start-up delays
- Develop and execute customized site start-up strategies
- Serve as subject matter expert for start-up processes and regulations
Regulatory & Compliance Excellence
- Ensure adherence to ICH-GCP guidelines and local regulatory requirements
- Review and approve essential start-up documents
- Conduct pre-study site assessments and initiation visits
- Maintain sites in audit-ready state throughout start-up phase
Relationship Management
- Build and maintain strong investigator and site staff relationships
- Collaborate with cross-functional teams to streamline start-up processes
- Provide expert guidance to site personnel on start-up requirements
- Act as primary point of contact for sites during activation phase
Mentorship & Process Improvement
- Train and mentor junior CRAs on start-up best practices
- Contribute to start-up process improvements and standardization
- Share start-up metrics and insights with project leadership
- Develop and update start-up tools and templates
⭐ Your Profile: Qualifications & Experience
Essential Requirements
- Advanced degree in Life Sciences, Nursing, Medicine, or related field
- Extensive CRA experience with proven start-up specialization
- Comprehensive knowledge of ICH-GCP guidelines and regulatory submissions
- Experience with site qualification, initiation, and activation processes
- Willingness to travel up to 60% (domestic & international)
Technical Expertise
- Proficiency in clinical trial management systems
- Strong understanding of start-up documentation requirements
- Experience with electronic Trial Master File (eTMF) systems
- Knowledge of local regulatory landscapes and requirements
Leadership Competencies
- Excellent problem-solving and decision-making skills
- Strong mentoring and training capabilities
- Advanced stakeholder management and influence
- Strategic thinking and process improvement mindset
- Ability to manage multiple complex start-up projects
💫 Why Join ICON as an SSU CRA?
Career Advancement
- Senior-level role with specialized start-up focus
- Leadership development and mentorship opportunities
- Pathway to Site Management and Leadership positions
- Exposure to global clinical trials and innovative therapies
Professional Impact
- Critical role in accelerating clinical trial timelines
- Direct influence on study success through efficient site activation
- Opportunity to shape start-up processes and best practices
- Work with cutting-edge therapies and complex study designs
Comprehensive Benefits
- Competitive senior-level compensation package
- Enhanced travel benefits and accommodation support
- Comprehensive health and wellness programs
- Professional development and certification support
- Global networking and collaboration opportunities
✨ Ready to Lead Site Start-Up Excellence?
If you're an experienced CRA with specialized start-up expertise and a passion for mentoring others, we want to hear from you. Join us in driving clinical trial success through exceptional site activation strategies and leadership.
Apply Now & Drive Clinical Trial Acceleration
