Study Start Up Associate I

ICON plc

IVD Study Start-Up Associate facilitating site activation and regulatory submission activities in clinical studies. Collaborating with teams to ensure compliance with regulations and timelines.

Posted 7/9/2026full-timeRemote • 🇬🇧 United KingdomJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in preparing and coordinating regulatory submissions and clinical trial documentation while ensuring compliance with ICH-GCP guidelines and applicable regulations. Strong organizational and communication skills are essential for managing multiple priorities and stakeholder interactions effectively.

Highest-signal resume keywords

Regulatory AffairsClinical ResearchStudy Start-UpStakeholder ManagementIn Vitro Diagnostics (IVD)

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Documentation PreparationClinical Trial ApplicationsEthics Committee SubmissionsStudy Protocol DevelopmentInformed Consent Form ManagementInvestigator Brochure PreparationRegulatory Requirements KnowledgeClinical Research ProcessesUK Clinical Study SubmissionsIssue Resolution

Soft Skills

Organizational SkillsCommunication SkillsStakeholder Management Skills

Industry Keywords

ICH-GCP GuidelinesCROHealthcare EnvironmentStudy ActivationInspection-Ready Records

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Preparing, compiling, and submitting regulatory and ethics documentation, including clinical trial applications and ethics committee submissions
Coordinating with internal teams, sponsors, regulatory authorities, and investigative sites to secure required approvals and authorisations for study initiation
Maintaining accurate and inspection-ready records of regulatory submissions, approvals, and essential study documents
Supporting study teams in the development, review, and management of key study documentation, including protocols, informed consent forms, and investigator brochures
Participating in study start-up meetings, providing guidance on regulatory requirements, timelines, and activation strategies
Tracking study start-up milestones and proactively identifying and resolving issues that may impact activation timelines
Ensuring all activities are conducted in accordance with applicable regulations, ICH-GCP guidelines, and company SOPs

Requirements

What you’ll need

Bachelor's degree in Life Sciences or a related scientific discipline
Previous experience in clinical research, study start-up, regulatory affairs, or site activation within a CRO, sponsor, or healthcare environment
Hands-on experience preparing and coordinating UK clinical study submissions
Knowledge of applicable regulatory requirements and clinical research processes
Strong organisational skills with the ability to manage multiple priorities and timelines
Excellent communication and stakeholder management skills
Experience in In Vitro Diagnostics (IVD) studies is highly desirable
Willingness to travel within the UK occasionally, approximately 5%

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