Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.
This role is office-based in Banja Luka, Bosnia and Herzegovina
Communication and Site Management
- Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team, and with other PSI departments
- Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
- Ensures proper administration of sites and vendors payments, as applicable
- Ensures regulatory and ethics committee submissions and notifications
- Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
- Supports the organization of internal team meetings including preparation of agendas and minutes, and also of Investigator’s Meetings
- Maintains study-specific and corporate tracking systems
Document Management
- Maintains Trial Master File (TMF)
- Performs TMF review and oversight at country and site level
- Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
- Revises and checks translation status
Safety Management
- Ensures proper safety information flow with investigative sites
- College/University Degree in Medicine or Pharmacy
- Prior administrative experience is a plus
- Proficiency in standard MS Office applications
- Full working proficiency in English, Bosnian and Serbian
- Good organizational and planning skills, problem-solving abilities, and 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
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
Please submit your resume in English.