Study Start-Up Associate II

ICON plc

Study Start-Up Associate II at ICON initiating clinical trials while ensuring compliance with regulatory requirements and improving site activation processes. Collaborative role requiring relevant experience in clinical research.

Posted 7/7/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates expertise in clinical trial site start-up processes, ensuring compliance with regulatory requirements and effective communication with stakeholders. Proficient in managing essential documents and metrics to enhance site activation efficiency.

Highest-signal resume keywords

Clinical Research Site Start-UpRegulatory ComplianceSite Essential Document ReviewMicrosoft Excel ProficiencyData-Driven Decision Making

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

Clinical Trial ManagementSite Activation ActivitiesICD PreparationSite Performance MetricsEssential Document CollectionClinical Study ProtocolsETMF AccuracySite Communication TrackingProblem ResolutionOrganizational Skills

Soft Skills

Strong Communication SkillsDecision MakingNegotiation SkillsOrganizational Skills

Tools & Technologies

Microsoft WordMicrosoft PowerPoint

Industry Keywords

CROPharmaceutical IndustryClinical OperationsStudy Startup TeamTAU Partners

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
Work directly with assigned sites on all site related essential document collection and review
Assist with Country level ICD preparation
Review and approve site level ICDs
Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes
Ensure standards are applied to the SSU processes across projects
Review site essential documents for start-up including but not limited to: ICF, FDF, 1572, CVs etc
Promptly recognize and improve potential site activation delays and escalate to appropriate team members
Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned
Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team
Review and provide feedback to management on site performance metrics
Ensure accuracy and completeness of the eTMF for assigned sites during start up

Requirements

What you’ll need

BS degree or international equivalent
2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor
Ability to explain data to facilitate decision making processes to be data driven
Knowledge and understanding of clinical study protocols and essential documents
Strong organizational skills, decision making, communication and negotiation skills
Proficient in Microsoft Excel, Word, and PowerPoint

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