Study Start Up Associate I

AssociateGeneralFull TimeRemoteMid LevelTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

1 day ago

Salary

0

Seniority

Mid Level

Bachelor DegreeEnglishGoogle Cloud Platform

Job Description

Study Start Up Associate I

ICON plc

• 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

Job Requirements

  • 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

  • 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

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