Live opening · Posted 7 days ago
The key details from the original listing.
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Description supplied by the original job listing.
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
Employment type
Full-time
Work arrangement
No
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