Clinical Trial Support Specialist (CTA)

Adaptimmune Limited
10 Feb 2018
15 Feb 2018
Contract Type
Full Time
Adaptimmune are looking for a Clinical Trial Support Specialist (CTA) to work in our Abingdon office.

In this role you will 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.

Study Start up

- Support 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

Qualifications and Experience:

Required: Bachelor's degree (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience

Desired : Previous experience as a CTA within Pharma/CRO desired but not a necessity

Similar jobs

Similar jobs