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Clinical Trial Support Specialist/Senior CTSS (CTA/sCTA)

Primary Responsibility

Conduct and facilitate activities associated with start-up activities including preparation of site submission packages,

interaction with sites to ensure all required documents are in place for site activation, in accordance with relevant regulations, SOPs, and study specific procedures

 

As a Senior CTSS you will additionally provide support for other activities such as site qualification, monitoring and clinical study report writing.

Key Responsibilities

Study Start up

  • Support EU/US site pre-qualification
  • Assign site and PI numbers
  • Review and validate site identification list
  • Follow up with site on ethics submission and approval received (initial submission and amendments)
  • Review feedback/comments from sites on the ICF to ensure compliance with ADAP requirements; resolve changes requested by the site and approve with support from Clinical Team, safety and legal.
  • Prepare, collect and negotiate Confidentially Agreements (CDA) as required.  Resolve CSA changes requested by the site and approve any change in CSA language with support from Clinical Team and Legal; Collect internal CSA signatures
  • Interface with internal TMF group to ensure site submission package is sent and start up documents are submitted to TMF

Study Conduct

  • Manage SAE email distribution
  • Ensure good understanding of project scope, milestones, budgets to confirm payment of invoices
  • Submit relevant documents to the Trial Master File
  • Create and maintain Study Procedures Manual and ICF as needed
  • General Clinical Operations Support
  • Liaise with other internal departments to avoid duplication of effort across studies around completion of forms (eg, IBC forms), vendor form updates, etc.
  • Manage the SNAP (subject number assignment program) across studies; Maintain relevant SOP
  • Proactively keep clinical scientists and manager informed about work progress and any issues (including conflicting priorities and free capacity)
  • Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Adaptimmune SOPs, other Adaptimmune training requirements, and study specific procedures and training
  • Escalate any issues that require immediate action to the clinical scientist
  • Proactively work with team members to meet project goals
  • Support metric tracking and protocol deviation quarterly review

 

Other Operational Aspects in the senior role will include:

  • Contribute to trip reports when in attendance and participating at the site
  • Support monitoring visits as needed
  • Support medical writing activities

Qualifications & Experience

Required:

  • Bachelor’s degree (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
  • Previous experience as a CTA/CTSS within a pharmaceutical, CRO or Biotech

Skills & Compentencies

Required

    • Client focused approach to work
    • Ability to manage multiple and varied tasks with enthusiasm
    • Attention to detail
    • Strong interpersonal, verbal, and written communication skills
    • Sense of urgency in completing assigned tasks
    • Effective time management in order to meet daily metrics, team objectives, and department goals
    • Good presentation skills

Decision Making Authority

Although good judgement when encountering issues is required for this position, the ultimate decision for action will be made at a higher level.  Escalate issues to the Head of Site and Vendor Management or Clinical Scientist

 

Other Requirements

-  Valid driver's license
- Fluent in local office language and in English, both written and verbal

- Ability to travel internationally (valid passport).
 

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