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Clinical Study Assistant

  • Location:

    Mechelen

  • Contact:

    Santina Fourneaux

  • Job type:

    Contract

  • Industry:

    Biotechnology

  • Contact email:

    santina_fourneaux@oxfordcorp.com

For one of our clients, a fast-growing biotech company, we are looking for an experienced Clinical Trial Assistant.

Job description

Providing operational support to phase I to III clinical studies under the leadership of the assigned project leaders as well as general administrative support to the Clinical Operations department. In exceptional cases providing agreed upon support to other departments within Development.


Responsibilities

  • Build a sound relationship with the people you support, making sure their timely support can be guaranteed for those activities agreed upon.
  • Provide support in the set-up of study/program specific meetings with internal as well as external members.
  • Attend relevant study/program related meetings. For meetings hosted by internal staff, this includes ensuring finalization and distribution of meeting minutes.
  • Develop and maintain system related documents and training material (for example for CTMS or eTMF).
  • Set-up and maintenance of clinical study databases/systems throughout the study, as required.
  • Create and maintain appropriate tools or trackers as required for agreed study related activities (for example collection of signatures for submission documents, requesting insurance certificates, follow-up on information needed for the activation of sites etc.).
  • Support the collection of sponsor specific clinical study submission documents making sure these are legalized, signed and notarized as applicable and in a timely fashion to meet submission timelines.
  • Support the project leaders in proper TMF management, review (i.e. Quality checks delegated to CTA) and archiving (coordination, consolidation of TMF documents).
  • Support the organization of Investigator Meetings in collaboration with the contracted meeting planner.
  • Create and maintain relevant study related contact lists. 
  • Distribute Study Newsletters/Correspondence to study related contacts as agreed upon by the project leader.
  • Support the review and tracking of invoices and vendor payments.
  • Maintain the departmental intranet on SharePoint.
  • Provide support in the set-up of departmental and cross-departmental meetings including the creation, finalization and distribution of meeting minutes.
  • Support the follow-up on Confidentiality Agreements.
  • Track IBs distributed by the study team.
Requirements
  • Minimum 2 to 3 years previous experience as a CTA
  • Ability to work autonomously
  • Service-minded
  • Effective time management and organizational skills
  • Ability to establish and maintain effective working relationships
  • Ability to work in a fast-paced environment
  • Good computer skills
  • Fluent in English, good command of Dutch and French