Site Management Associate
Banja Luka - Bosnia and Herzegovina
Job Summary
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 Investigators 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
Qualifications :
- College/University Degree (preferably Life Sciences)
- 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
Additional Information :
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.
Remote Work :
No
Employment Type :
Full-time
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more