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Senior Clinical Research Associate - Oncology (South Korea)

Role overview

Summary

This role is for a Senior Clinical Research Associate at Worldwide Clinical Trials, focusing on the successful delivery of clinical research studies in South Korea. You will collaborate with investigative sites, sponsors, and study teams to ensure data quality and patient safety while leading monitoring activities throughout the study lifecycle.

Qualifications

  • Medical Doctor (MD) degree or Pharmacy degree with at least 3 years of Clinical Research Associate experience; OR a four-year degree in a medical, biological, health, pharmacy, physical science, or related discipline with at least 5 years of Clinical Research Associate experience; OR a two-year college curriculum/equivalent education (nursing or life science preferred) with at least 7 years of Clinical Research Associate experience.
  • Extensive knowledge of clinical research processes, monitoring practices, and site management activities.
  • Strong understanding of FDA and/or EU regulations, ICH Guidelines, GCP, local regulatory requirements, and clinical trial SOPs.
  • Demonstrated experience across multiple therapeutic areas with the ability to function as a Lead CRA.
  • Proficiency in English and fluency in local language(s) required for countries under responsibility.

Responsibilities

  • Lead site qualification, initiation, monitoring, management, and close-out activities in accordance with study protocols, GCP, and regulatory requirements.
  • Evaluate site performance and protocol compliance while helping drive high-quality, timely clinical data collection.
  • Serve as a Lead CRA on global studies, coordinating monitoring activities and supporting other CRAs as needed.
  • Mentor and train site personnel and less experienced CRAs on study requirements, monitoring practices, and protocol adherence.

Key facts

Hard skills

Other skills

  • Microsoft Office
  • Communication
  • Time Management
  • Problem Solving
  • Social Skills

About the company

Worldwide Clinical Trials logo

Worldwide Clinical Trials

  • Clinical Research (CRO)
  • Large
  • 1,001–5,000
About Worldwide Clinical Trials  Worldwide Clinical Trials is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new treatments. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our team members who bring their expertise and a collaborative, personalized approach to each clinical program. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers. Our talented team of 3,000+ professionals spans 60+ countries, and embraces a culture of diversity, equity, inclusion, and belonging (DEI&B). We are united in cause with our customers to improve the lives of patients through new, innovative therapies. For more information on Worldwide, visit www.Worldwide.com.

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Job description

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. 


With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. 


Make an Impact as a Senior Clinical Research Associate at Worldwide


As a Senior Clinical Research Associate, you'll play a key role in ensuring the successful delivery of clinical research studies by partnering closely with investigative sites, sponsors, and study teams. Your work will directly support data quality, protocol compliance, patient safety, and the advancement of clinical research.

In this role, you'll lead and oversee monitoring activities across the study lifecycle, from site qualification and initiation through close-out. You'll also have opportunities to provide leadership, mentorship, and strategic input across global studies while helping sites maintain the highest standards of Good Clinical Practice (GCP) and regulatory compliance.

Working collaboratively with project teams and site personnel, you'll contribute to efficient study execution, support critical milestones, and help ensure reliable data that can make a meaningful impact on patient outcomes.


Where You'll Work


This is a home-based Clinical Research Associate role supporting sites across South Korea. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 8-10 days per month.

To best support our sites, we're seeking candidates who are based in South Korea. Travel will primarily be regional, with occasional travel to support sites in other locations as needed.


What You'll Do


  • Lead site qualification, initiation, monitoring, management, and close-out activities in accordance with study protocols, GCP, and regulatory requirements.
  • Evaluate site performance and protocol compliance while helping drive high-quality, timely clinical data collection.
  • Serve as a Lead CRA on global studies, coordinating monitoring activities and supporting other CRAs as needed.
  • Review source documentation, informed consent processes, safety information, and case report forms to ensure data integrity and patient safety.
  • Mentor and train site personnel and less experienced CRAs on study requirements, monitoring practices, and protocol adherence.
  • Partner with Project Management and study teams to track study milestones, evaluate deliverables, and support successful study execution.
  • Prepare and review monitoring reports, regulatory documentation, and essential study records, ensuring accurate Trial Master File maintenance.
  • Support investigator meetings, study team training, bid defenses, and the development of study-specific tools, plans, and templates.
  • Maintain strong communication with investigative sites and provide ongoing guidance to facilitate efficient study conduct and query resolution.

What You'll Bring


  • Medical Doctor (MD) degree or Pharmacy degree with at least 3 years of Clinical Research Associate experience; OR a four-year degree in a medical, biological, health, pharmacy, physical science, or related discipline with at least 5 years of Clinical Research Associate experience; OR a two-year college curriculum/equivalent education (nursing or life science preferred) with at least 7 years of Clinical Research Associate experience.
  • Extensive knowledge of clinical research processes, monitoring practices, and site management activities.
  • Strong understanding of FDA and/or EU regulations, ICH Guidelines, GCP, local regulatory requirements, and clinical trial SOPs.
  • Demonstrated experience across multiple therapeutic areas with the ability to function as a Lead CRA.
  • Experience using Microsoft Office, electronic data capture (EDC) systems, and IxRS platforms.
  • Excellent communication, organization, time management, problem-solving, and interpersonal skills.
  • Proficiency in English and fluency in local language(s) required for countries under responsibility.
  • Experience in full-service monitoring PREFERRED.

Discover the Difference


We love knowing that someone is going to have a better life because of the work we do.  Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us onLinkedIn.


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