Senior Clinical Research Associate – Oncology

Worldwide Clinical Trials

. Lead site qualification, initiation, monitoring, management, and close-out activities in accordance with study protocols, GCP, and regulatory requirements .

Posted 11/5/2026full-timeRemote • South KoreaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of clinical research processes, monitoring practices, and regulatory requirements, with a strong ability to lead site qualification and manage clinical trials effectively. Proficient in maintaining data integrity and patient safety while mentoring and training site personnel and CRAs.

Highest-signal resume keywords

Clinical Research Associate ExperienceKnowledge Of GCP And Regulatory RequirementsLead CRA ExperienceProficiency In English And Local Language(s)Experience With EDC Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ProcessesMonitoring PracticesSite Management ActivitiesFDA RegulationsICH GuidelinesTrial Master File MaintenanceData IntegrityProtocol ComplianceSafety Information ReviewFull-Service Monitoring

Soft Skills

Excellent CommunicationOrganization SkillsTime ManagementProblem-Solving SkillsInterpersonal Skills

Tools & Technologies

Microsoft OfficeElectronic Data Capture (EDC) SystemsIxRS Platforms

Certifications & Qualifications

Medical Doctor (MD) DegreePharmacy Degree

Industry Keywords

Clinical TrialsStudy ProtocolsRegulatory DocumentationInformed Consent ProcessesTherapeutic Areas

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
Support sites across South Korea and travel to investigative sites approximately 8–10 days per month

Requirements

What you’ll need

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

Benefits

Comp & perks

Home-based work arrangement
Opportunity to learn and grow
Leadership, mentorship, and strategic input opportunities
Collaborative and inclusive work environment
Professional development through mentoring and training opportunities