Description
Perform daily administrative activities to ensure a complete and accurate Trial Master File delivery.
Responsibilities:
- Trial and site administration:
+ Track and report essential documents and safety reports + Collate and distribute study tools and documents + Update clinical trial databases and trackers + Manage clinical supply and non-clinical supply in collaboration with other country roles + Coordinate labeling requirements and translation change requests
- Document management:
+ Prepare documents and correspondence + Collate, distribute, and archive clinical documents + Assist with eTMF reconciliation and quality control + Update manuals and documents + Document destruction of clinical supplies + Prepare investigator trial file binders
- Regulatory & Site Start-Up responsibilities:
+ Provide and collect forms and lists for site evaluation and validation + Obtain and track study insurance certificates + Support preparation of submission packages for regulatory agencies + Publish study results where required
- Budgeting, Agreement and Payments:
+ Collaborate with finance representatives to develop country and site budgets + Track and report negotiations + Maintain tracking tools and contract templates + Calculate and execute payments + Ensure compliance with financial procedures
Qualifications:
- Completed job training or Bachelor's Degree
- Previous experience as a Trainee, CTA, or Coordinator is an advantage
- Minimum 1-2 years in Clinical Research or relevant healthcare experience
- Computer skills in Microsoft Word, Excel, and PowerPoint
- Written and verbal communication skills in Czech and English
- Effective time management and organizational skills
- Awareness of clinical research regulatory requirements, including GCP and ICH guidelines