Study Start Up Specialist
Novella Clinical
Brussels-Captial Region-Brussels-BEL
3 dagen geleden

Description

Novella Clinical is looking for an experienced ClinicalStudy Start-up professional to join our new Study Start-Up Unit in Belgium.

  • The Study Start-up Specialists are responsible for conducting andfacilitating specific start-up activities that may include siteidentification, feasibility, essential document collection and review, ICFcustomization, EC and CA submissions, preparation and negotiation of ClinicalSite Contracts for France.
  • This is a new and pivotal position within the Europeanoperation as we look to streamline the start-up process and introduce the StudyStart up department.

    Qualifications

  • Review and negotiate site regulatory documents and contracts with sites for agreement on wording and budgets. This will be done with consultation from the regulatory lead and contracts lead regionally.
  • Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
  • Review and provide feedback to SSU manager on site performance metrics.
  • Work with regulatory team members and SSU manager to secure authorization of regulatory documents.
  • Responsible for the collection and maintenance of the current Regulatory / Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned country.
  • Responsible for the translation and co-ordination of translations for documents required for submission.
  • Responsible for liaising with local CRA / CTM, Contract Specialist, and Regulatory Lead to enable a rapid clinical trial start up.
  • Work with legal team members and SSU Manager to secure authorization of contracts.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • May participate in feasibility and / or site identification activities.
  • Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
  • Collects and reviews initial regulatory packets and site contracts for investigator sites.
  • Assures that SSU functions interface effectively with all other key operating departments within Novella. Working with Clinical Operations, Project Management, Site Identification, additional SSU specialists, Regulatory and Contracts group on SSU project specific status and deliverables.
  • Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
  • Create, review and customization of country / site specific Informed Consent Forms (ICFs).
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