Study Start Up Associate II

ICON plc

. Lead preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications .

Posted 9/22/2026full-timeRemote • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs and clinical research coordination, with a strong understanding of ICH-GCP guidelines and local regulatory requirements. Proven ability to manage regulatory submissions and collaborate effectively with cross-functional teams to enhance study start-up processes.

Highest-signal resume keywords

Regulatory Document PreparationClinical Trial ApplicationsICH-GCP ComplianceProject ManagementStakeholder Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsClinical Research CoordinationStudy Start-Up ActivitiesRegulatory Submissions ManagementDocument Review and Approval

Soft Skills

Excellent CommunicationInterpersonal SkillsOrganizational SkillsProactive LearningCollaboration

Industry Keywords

Clinical TrialsSOPsStudy Site ActivationRegulatory Agency CommunicationsEthics Committee Submissions

About the role

Key responsibilities & impact

Lead preparation and submission of 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
Collect, prepare, review, approve, process, and track regulatory and site-level critical documents required for study site activation in accordance with applicable SOPs, regulations, guidelines, and ICH/GCP

Requirements

What you’ll need

1+ years of clinical research experience in regulatory affairs, clinical research coordination, and/or study start-up activities
Experience at a clinical research site (preferred)
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
Proactive approach and strong willingness to learn and develop new skills
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Bachelor's degree, preferably in a life sciences, healthcare, or related field
Legal right to work in the United States

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