Clinical Trial Assistant – Bordeaux H/F

Excelya>Full-time>Clinical Trial Assistant – Bordeaux H/F

Job description

Established in 2014, Excelya is a ‘people centered’ contract research organization (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop-shop service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.

 

Mission:

The Clinical Trial Assistant (CTA) supports the project teams in the administration, maintenance and coordination of all logistical aspects of the clinical trials in accordance with the applicable ICH-GCP guidelines and Standard Operating Procedures (SOPs). The CTA works closely with the Project Manager and the Clinical Research Associate (CRA) responsible for the relevant project to contribute to the efficient completion of all logistical and administrative matters related to clinical projects.

 

Responsibilities :

  • Follow Excelya’s and the client’s standard operating procedures (SOPs), guidelines and relevant local and international legislation.
  • Prepare and collect all required study documents to the (e)TMF in order to obtain approval of the centre’s regulatory file prior to the centre’s initiation visit, according to the sponsor’s deadlines.
  • Collect the initial essential documents required for shipment of the drug.
  • Ensure that the (e)TMF contains all documents required during the conduct of a clinical trial.
  • Ensuring that the (e)TMF documents are filed in an orderly manner as required by the sponsor’s deadlines, and resolving any issues within the required timeframe.
  • Prepare and update clinical trial files (ISFs/(e)TMFs) throughout the study and ensure archiving of study related documents after the end of the trial.
  • Coordinate the translation process as required by Excelya or the sponsor.
  • Preparing submission packages and investigator notifications.
  • Coordinate and ensure submission of CRFs and other study related documents.
  • Update trackers under his/her responsibility.
  • Prepare documents and submission packs for investigators and local ECs and arrange for their dispatch to the centres.
  • Assist the SSUS team in the collection of site-specific documents for timely submissions.
  • Update systems and databases. Provide effective internal support to CRAs during centre visits.

Profile:

You will be the interface between all the actors involved in a clinical study. You will be rigorous, organised, service-oriented and have excellent interpersonal skills.

You have a minimum of two years experience as a clinical operations assistant in a CRO and/or pharmaceutical laboratory.

We are looking for a person with successful experience in the function: administrative management of clinical trials.

Good level of oral and written English required and proficiency in computerized office tools.

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