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CTA/Study Start-up Specialist

For a very well-known pharmaceutical industry, we are looking for a CTA with experience in the Informed Consent Form and study start up/submission process with good knowledge of Dutch, French and English. This position is a long-term opportunity as Consultant.

Job description
As a Clinical Trial Assistant/Study Start up Support Specialist, you will combine start up with CTA responsibilities.
You will assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. You will also have several responsibilities related to ICF adaptation.

Responsibilities

ICF Adaptation:

  • Track and adapt local template
  • Follow-up with the vendors to convert global to local ICF template
  • Check of the ICF after vendor's conversion;
  • Prepare local version for translation into Dutch and French;
  • Follow-up on the comments received from EC

Submissions and other documentation:

  • Liaise with clinical team to help compile initial and amended regulatory document package for the central and local IRB/IECs and sites
  • Track the status of regulatory readiness and alert the Clinical Study Manager appropriately to any issues/challenges in getting sites ready.
  • If relevant, work with translating agencies to ensure translation of relevant clinical study documents.
  • Ensure appropriate versions of legal documents (Confidentiality Agreements, CTA) are used and ensure database is kept current. In collaboration with local clinical team responsible for contract management with investigators, vendors…. Liaise with legal to track and process agreements.
  • Responsible for efficient input of trial related documents/communications in to CREDI.
  • In collaboration with CSMs and CRAs, responsible to set-up and keep country and site TMFs continuously up to date according to regulatory and internal requirements.

Clinical Trial Supplies:

  • Assist local trial team with the creation, ordering, and mailing of any study tools including recruitment materials as well as newsletters, email communications, faxes, etc.
  • Support local trial team with ordering/tracking/mailing of any necessary trials supplies including the regulatory binder, lab kits.
  • Support the CSM with the coordination of internal and external suppliers, including customs, to ensure import of all clinical trial supplies (including drug supply)
  • Coordinate shipment of clinical trial supplies to local sites
  • Coordinate relabeling of IMP at warehouse when needed.

Finance:

  • Track, process and release payments to vendors in collaboration with local study team and finance.

General

  • May assist with endpoint tracking or other specific tracking needs of trial
  • May assist with setting up webcasts, TCs or other meeting formats.
  • Supports local trial team with Investigator Meeting attendance and ensures training records are archived according to SOPs.
  • Ensure that all reporting systems are kept up to date and reports discrepancies to local trial team: IVRS/Oracle/Impact/ClinAdmin, throughout trial conduct

Profile

  • University degree in Life sciences or Administration
  • Min. 2 to 3 years' experience as a Clinical Trial Assistant and preferably in ICF adaptation and/or other start-up activities
  • Good knowledge of Dutch, French and English
  • Strong organization and planning skills
  • Ability to work both independently and in team
  • Ability to multitask
  • Eye for detail
  • Flexible
  • Good communication and interpersonal skills
  • Existing right to work in Europe required

Benefits

  • A balanced salary package based on your capabilities and experience.
  • Full-time position with a permanent contract as Consultant
  • Flexibility in term of home-working possibilities.

Vacancy number : 18155