Study Start Up Associate II

ICON plc

Study start-up specialist launching clinical trials for ICON, a global healthcare intelligence and clinical research organization. Managing regulatory submissions, approvals, and site activation.

Posted 8/20/2026full-timeRemote • 🇧🇷 BrazilJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading clinical trial initiation and managing regulatory submissions, with a strong understanding of ICH-GCP and local regulatory requirements. Proven ability to coordinate with stakeholders and enhance study start-up processes through effective project management and communication skills.

Highest-signal resume keywords

Clinical Trial InitiationRegulatory SubmissionsICH-GCP ComplianceProject ManagementStakeholder Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchRegulatory AffairsStudy Start-Up ActivitiesRegulatory Document PreparationProcess Improvement

Soft Skills

Organizational SkillsCommunication SkillsInterpersonal Skills

Industry Keywords

Clinical TrialsEthics Committee SubmissionsRegulatory RequirementsStudy ActivationCross-Functional Collaboration

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the initiation of clinical trials
Contribute to site start-up and activation activities
Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
Manage 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
Reasonable accommodations during the recruitment process