đŹÂ Advance Clinical Research: CRA II - Post-Marketing Surveillance (Home-Based, South Korea)
Join ICON plc as a CRA II specializing in Post-Marketing Surveillance and become the guardian of drug safety across South Korea. This home-based role empowers you to monitor real-world treatment outcomes while ensuring compliance with Korean regulatory standards, all from the comfort of your home with strategic travel across the peninsula.
As a world-leading healthcare intelligence organization, we're seeking an experienced CRA to oversee post-marketing studies and surveillance activities. If you're passionate about ensuring long-term medication safety and thrive in patient-focused research environments, this is your opportunity to build a meaningful career while exploring South Korea's dynamic healthcare landscape.
đŻÂ Your PMS Mission: Key Responsibilities
Site Management Excellence
- Conduct comprehensive site qualification, initiation, monitoring, and close-out visits for post-marketing surveillance studies across South Korea
- Ensure strict protocol compliance and data integrity while maintaining focus on patient safety in real-world settings
- Collaborate with Korean investigators and site staff to facilitate smooth study conduct and address local requirements
- Build strong relationships with healthcare providers across hospitals and clinics throughout South Korea
Data Quality & Compliance
- Perform meticulous data review and rapid resolution of queries to maintain highest-quality clinical data standards
- Ensure all post-marketing activities comply with Korean MFDS regulations and international ICH-GCP guidelines
- Contribute to preparation and review of essential study documentation, including protocols and surveillance reports
- Monitor adverse event reporting and product quality complaints in accordance with Korean regulatory requirements
Strategic Site Partnerships
- Serve as ICON's primary liaison with Korean clinical sites, providing expert guidance on PMS requirements
- Identify and resolve site-specific challenges through proactive communication and problem-solving
- Support sites in maintaining inspection readiness for Korean regulatory audits
- Facilitate training and ongoing support for site staff on PMS protocols and procedures
â Your Profile: PMS Expertise
Essential Qualifications
- Bachelor's degree in Scientific or Healthcare-related field
- Minimum 2 years experience as Clinical Research Associate, preferably with post-marketing or observational study exposure
- In-depth knowledge of clinical trial processes and ICH-GCP guidelines
- Understanding of Korean MFDS regulations and local regulatory requirements
Technical Competencies
- Experience with site management and monitoring activities in Korean healthcare settings
- Strong understanding of post-marketing surveillance methodologies and requirements
- Knowledge of real-world evidence generation and observational study designs
- Familiarity with Korean clinical research environment and healthcare system
Professional Attributes
- Strong organizational skills with exceptional attention to detail
- Excellent communication abilities in Korean and English for effective cross-cultural collaboration
- Independent work ethic with ability to manage multiple sites and priorities
- Adaptive problem-solving skills for addressing site challenges efficiently
Travel Requirements
- Ability to travel minimum 60% across South Korea (international and domestic)
- Valid driver's license for site visits requiring road travel
- Flexibility for fly-and-drive assignments throughout the peninsula
- Comfort with extensive travel while maintaining monitoring quality
đŤÂ Why Build Your CRA Career at ICON Korea?
Meaningful Impact in Healthcare
- Play a crucial role in ensuring long-term medication safety for Korean patients
- Contribute to real-world evidence generation that informs clinical practice
- Work across diverse therapeutic areas and treatment settings in South Korea
- Support the safe use of medications in real-world clinical practice
Home-Based Flexibility with Purpose
- 100% remote work base with comprehensive technology support
- Strategic travel across South Korea's vibrant healthcare institutions
- Balance autonomous field work with virtual team collaboration
- Explore Korea's diverse regions while advancing your clinical research career
Professional Growth in PMS
- Specialize in high-demand post-marketing surveillance expertise
- Clear pathway to Senior CRA and Clinical Team Lead positions
- Exposure to innovative real-world evidence methodologies
- Opportunities for therapeutic area specialization
Competitive ICON Korea Benefits
- Attractive salary package with performance incentives
- Comprehensive health insurance for you and your family
- Global Employee Assistance Programme with Korean language support
- Generous annual leave with Korean public holidays
- Retirement planning benefits and life assurance coverage
- Travel allowance and expense coverage for site monitoring
- Professional development and certification opportunities
â¨Â Ready to Shape Drug Safety in South Korea?
If you're an experienced CRA with passion for patient safety and interest in post-marketing surveillance, we encourage you to apply. This CRA II role offers the unique opportunity to advance your career while ensuring the ongoing safety and effectiveness of treatments used by patients across South Korea.
Apply Now and become ICON's next PMS expert in South Korea!
