Clinical Trial Support Specialist
1 week ago
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
About the Team:
The Clinical Development Operations team is responsible for execution of clinical trials in multiple solid tumors, and are responsible for developing and maintaining excellent relationships with the Investigators, recruiting patients into clinical trials delivering high quality data to support the early and late phase development of these transformative therapies.
In this role, you will work as part of the Clinical Study Team, to conduct and facilitate the smooth running of Adaptimmune clinical trials from study start up through to study close out, in accordance with relevant regulations, SOPs, and study specific procedures.
The Clinical Trial Support Specialist will be responsible for assisting the Clinical Scientist with the day-to-day coordination and administration activities required in the running of Adaptimmune clinical trials.
Activities will include but are not limited to preparation of site submission start up packages, interaction with sites to ensure all required documents are in place for site activation, filing of study documents in the study Trial Master File and coordinate and prepare study documentation including ICFs, Study Manuals etc.
KEY RESPONSIBILITIES
Study Start up
- Support EU/US site prequalification
- 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
- Work with CRO to ensure study start up activities are completed within agreed timelines
- Support Clinical Team with the organisation and conduct of Site Qualification and Site Initiation visits
- Support with the drafting and review coordination of clinical documents required for study start up (i.e. Protocol, IB, ICFs and study manuals)
Study Conduct
- 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.
- 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
- Work with CROs and vendors to ensure the smooth operation of ongoing study activities
- Support Clinical Team with the organisation and conduct of Site Monitoring visits
- Support with the drafting and review coordination of clinical documents revisions (i.e. Protocol, IB, ICFs and study manuals)
- Support Clinical Team with the organisation of study and site wide meetings. Where required present and lead these meetings.
Other Operational Aspects
- Support review and creation of clinical SOPs as required
- Proactively review current clinical processes and implement process improvement with assistance from Clinical Team
QUALIFICATIONS & EXPERIENCE
- Bachelor's degree (biological science, pharmacy or other healthrelated discipline preferred), nursing or other relevant qualification/experience
- Some experience supporting clinical activities
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