Clinical Study Assistant
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Job Description
Clinical Study Assistant supporting pharmaceutical clinical trials for ICON. Reviewing study documentation, regulatory readiness, trial systems, vendors, and close-out activities remotely from Warsaw.
Responsibilities:
- Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols
- Collaborate with Clinical Operations/Study Manager, study teams, and CROs to support clinical study activities
- Perform departmental tasks as needed
- Review study documentation, including essential document packets, study plans, and informed consent forms
- Support and oversee risk-based monitoring
- Attend key team meetings and prepare minutes for selected studies
- Support regulatory inspection readiness, including SOP lists and storyboard collation
- Support clinical trial systems such as CTMS/TMF and associated activities
- Support vendor contract administration
- Support study close-out activities, including financial reconciliation
- Support additional ad-hoc activities as agreed with managers
- Collaborate with Legal, Insurance, R&D functions, CROs, and external vendors
Requirements:
- Bachelor's degree in a scientific or healthcare-related field or equivalent international degree required
- 1-2 years’ experience in pharmaceutical industry, clinical research organization as CTA or Study Coordinator
- Experience in Phase 2 and 3 studies and global/international studies is advantageous
- Must have experience in Veeva system
- Experience working across multiple therapeutic areas (including oncology) is advantageous
- Knowledge in global/regional regulatory and compliance requirements for clinical research
- Demonstrated excellence in task management and cross-functional collaboration
- Excellent communication skills
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Fluent business English (oral and written)
- Ability to work collaboratively in a fast-paced environment with attention to detail
- Willingness to travel as required (approximately 10%)
- Legal right to work in Poland
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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