GW
Fortrea
Fortrea·3 days ago

Start-up specialist

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Location

onsite, Seoul, Seoul, South Korea

Commitment

Full Time

Level

Junior (<2 years)

Required skills

Clinical trial managementSite start-upRegulatory complianceICH/GCP guidelinesProject managementDocumentation managementIRB/EC submissionsICF negotiationsIMP releaseCommunicationOrganizational skillsAdministrative skillsComputer literacy

Job Description

Job Overview:

The Study Start-Up Specialist supports site start-up activities from potential site identification through site activation, ensuring timely delivery in compliance with applicable regulatory requirements and ICH/GCP guidelines. The role works closely with study teams, internal stakeholders, and site staff to coordinate start-up activities and support successful site activation.

Summary of Responsibilities:

  • Coordinate site-level start-up activities from receipt of a potential site list through site activation.
  • Collect and manage required site start-up and essential documentation, including CDAs and site questionnaires.
  • Support IRB/EC and regulatory submission activities and preparation of study-level essential document templates.
  • Manage ICF negotiations and facilitate escalation of issues where required.
  • Prepare and submit IMP Release Packages and support other site activation requirements.
  • Implement SSU strategies for the assigned region and collaborate with study teams, internal stakeholders, and site staff.
  • Track and project site activation timelines, proactively identifying and escalating risks or delays.
  • Maintain accurate and timely project status, financial information where applicable, and study information within relevant systems and tools.
  • Support consistent implementation of global SSU processes, standards, and tools.
  • Ensure all assigned activities are performed in compliance with applicable regulations, guidelines, and ICH/GCP requirements.

Qualifications (Minimum Required):

  • BS/BA degree or Associate degree with at least 2 years of experience in healthcare or direct clinical trial-related experience.
  • Knowledge of clinical trial conduct, drug development, and ICH/GCP guidelines.
  • Strong project management and organizational skills with the ability to manage multiple activities and timelines.
  • Excellent interpersonal, written, and verbal communication skills.
  • Strong administrative and computer skills.
  • Fluent in English.

Physical Demands/Work Environment:

General Office Environment. Minimal travel required (0-5%)

Learn more about our EEO & Accommodations request here.

Ready to join the team?

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