Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.
Site Management
- Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team
- Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
- Assists with handling administrative financial tasks
- Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
Other Communication
- Exchanges data, documents, and other information with the project team and other departments
- Provides assistance with organization of internal team meetings
- Prepares draft minutes of internal team meetings
- Assists with preparation, attendance and follow-up of Investigator’s Meetings, as applicable
- Under supervision, maintains study-specific and corporate tracking systems
Document Management
- Maintains Trial Master File (TMF)
- Perform TMF review and oversight at country and site level
- Prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists
- Provides assistance with translations
Safety Management
- Ensures proper safety information flow with investigative sites
Other Assistance
- Provides miscellaneous administrative project support (if applicable)
Requirements
- College/University Degree (Life Sciences)
- Prior administrative experience in Clinical Research / CRO environment, preferably in an international setting
- Proficiency in standard MS Office applications
- Good organizational and planning skills, problem-solving abilities, flexibility
- Detail-oriented, able to multi-task and work effectively in a fast-paced environment
- Team-oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects
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