Clinical Operations Specialist

ICON plc

. Contribute to site start-up and activation activities, taking responsibility for deliverables and working collaboratively .

Posted 10/30/2026full-timeRemote • Pennsylvania • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs and clinical research, particularly in study start-up activities, while effectively managing project timelines and stakeholder communications. Strong organizational skills and a solid understanding of regulatory requirements ensure compliance and efficiency in clinical trial processes.

Highest-signal resume keywords

Regulatory Document PreparationClinical Trial ApplicationsICH-GCP GuidelinesProject ManagementStakeholder Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsStudy Start-Up ActivitiesClinical ResearchRegulatory AffairsProcess Improvement

Soft Skills

Excellent CommunicationInterpersonal SkillsOrganizational Skills

Industry Keywords

Clinical TrialsEthics Committee SubmissionsRegulatory Agency CommunicationsLife SciencesLocal Regulatory Requirements

About the role

Key responsibilities & impact

Contribute to site start-up and activation activities, taking responsibility for deliverables and working collaboratively
Lead the 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 necessary approvals and authorizations for study initiation
Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities
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%)
Employment with ICON is contingent upon having the 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