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Clinical Study Assistant

For one of our clients, a medical devices company located in the north periphery of Brussels, we are looking for a Junior Clinical Study Assistant. For this entry-level position, we are looking for a junior candidate with a university degree in Life Sciences, who would like to start a career in clinical research and who is fluent in English.

Job Description

The Clinical Study Assistant provides clinical study administrative support to ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards and Client Standard Operating Procedures. Focus is on supporting administrative functions related to clinical study(s) which may include maintaining Clinical Trial Master File, site regulatory documents and device shipping and tracking. The Clinical Study Assistant supports with the coordination of safety board meetings which may include preparation of documents, coordination of meeting venue and travel. The Clinical Study Assistant provides assistance with core labs which includes tracking receipt of test results and invoices.

Responsibilities

File Management

  • Set-up and maintain Clinical Trial Master File.
  • Set-up and maintain site study files.
  • Maintain source document files.


Provides support to Clinical Project Teams

  • Assist with preparation for monitoring visits, such as internal regulatory file reviews and preparation, as appropriate for the assigned study.
  • Maintain records of investigational devices for all assigned regulated studies.
  • Facilitate the order and release of clinical investigational device exemption (IDE) device inventory.
  • Process invoices as needed and review payment report if applicable.
  • Run Institutional Review Boards (IRB) renewal status report and notify sites of pending IRB renewals.
  • Create site regulatory/subject binder(s) and ship to sites.
  • Assist with collection of site activation documents.
  • Organize and track shipment of study related documents.
  • Support and track shipment of project related equipment/data between centers, sponsor and core labs.
  • Assist with core labs such as tracking receipt of test results and invoices.
  • Attend project related meetings; write meeting minutes as applicable.
  • Assist with Investigator/Committee, etc. meetings such as travel arrangements, hotel, conference rooms, etc.
  • Collect, file and de-identify adverse event source documents.
  • Receive and file study related documents in the appropriate location.
  • Handles multiple assignments in a timely manner while meeting assigned deadlines.
  • Communicates and collaborates with all levels of employees, customers, contractors, and vendors.

Requirements

  • You have a university degree in Life Sciences or in Business Administration
  • You have a strong interest for clinical research. A first experience (internship or working experience in the Pharma/Medical Devices industry is a strong asset).
  • You are fluent in English (reading, writing and speaking)
  • You have a good Knowledge of MS office and an affinity with using systems
  • You have strong organizational skills and attentiveness to detail.
  • You are able to use discretion and handle sensitive/confidential information.
  • You are able to work independently when necessary.
  • You are able to exchange straightforward information, ask questions, and check for understanding.
  • Existing right to work in Europe required

Benefits

  • An attractive salary package
  • Full-time position
  • Flexibility in term of home-working.


Vacancy number: 18487