Senior Study Start Up Associate – Regulatory Affairs

ICON plc

Senior Study Start Up Associate at ICON responsible for site start-up and regulatory compliance in clinical studies. Leading initiatives to drive quality improvements and patient safety in global healthcare.

Posted 7/7/2026full-timeRemote • 🇰🇷 South KoreaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in conducting feasibility assessments, site identification, and regulatory submissions while ensuring compliance with ethical standards. Proficient in developing and reviewing informed consent forms to uphold patient safety and informed consent.

Highest-signal resume keywords

Clinical Study Start-Up ExperienceRegulatory Submission CoordinationFeasibility AssessmentInformed Consent DevelopmentFluency in English and Local Language

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Feasibility AssessmentSite IdentificationSite Contract NegotiationRegulatory ComplianceInformed Consent DevelopmentClinical Study Start-UpPatient Safety StandardsSubmission PreparationStudy Start Up ExpertiseClinical Research Knowledge

Soft Skills

CollaborationCommunicationProblem-SolvingLeadershipInsightful Contribution

Industry Keywords

Clinical ResearchEthics ComplianceSubject Information SheetsInformed Consent FormsMedical Science Background

About the role

Key responsibilities & impact

Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

Requirements

What you’ll need

A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
At least 3 years of experience or understanding of clinical study start-up requirements and activities
Fluency in the local language and English is essential

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways