About this role
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%)
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