Study Start Up Associate II

ICON plc

. Lead the initiation of clinical trials, ensuring compliance with regulatory requirements .

Posted 9/29/2026full-timeRemote • Brazil, ArgentinaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading clinical trial initiation and ensuring compliance with regulatory requirements, including ICH-GCP guidelines. Proficient in managing regulatory submissions and providing guidance on study start-up best practices.

Highest-signal resume keywords

Clinical Trial InitiationRegulatory ComplianceStudy Start-Up ActivitiesProject ManagementCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsClinical Trial ApplicationsEthics Committee SubmissionsRegulatory Agency CommunicationsProcess Improvement

Soft Skills

Organizational SkillsInterpersonal SkillsCollaboration

Industry Keywords

ICH-GCPClinical ResearchRegulatory AffairsLife Sciences

About the role

Key responsibilities & impact

Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
Contribute to site start-up and activation activities
Prepare and submit regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinate and liaise with internal and external stakeholders to obtain approvals and authorizations for study initiation
Manage and maintain accurate records of regulatory submissions, approvals, and correspondence
Provide guidance and support to study teams on regulatory requirements and study start-up best practices
Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency

Requirements

What you’ll need

Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Willingness to travel as required (approximately 5%)
Legal right to work in the country where the role is based

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