Clinical Trial Associate, Material Acquisition Platform (MAP)
Achilles Therapeutics, United Kingdom
Job Description
Achilles Therapeutics is a high growth clinical-stage biopharmaceutical company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. Originating from pioneering research at Cancer Research UK (CRUK), the Francis Crick Institute and University College London (UCL), we use DNA sequencing data from each patient, together with our proprietary PELEUS bioinformatics platform, to identify clonal neoantigens specific to that patient. From this, we develop personalized T cell therapies and currently have two programs in the clinic for the treatment of Non-Small Cell Lung Cancer and Metastatic Malignant Melanoma.
As a company, we are fast-paced and trailblazing. We are breaking new ground with our science, creating products that have never been made. As no one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organization, working together to solve novel problems. This entrepreneurial spirit and approach run through our company and those who thrive here can cope with anything that is thrown at them, enjoy ambiguity and thrive on making things happen even when there is not a detailed brief. We work hard and deliver a lot.
Role Summary
The Clinical Trial Associate (CTA) supports regional or global studies, in managing various administrative tasks such as meeting planning and generation of agenda’s and minutes, maintaining study tracking, filing and quality reviews, adhering to integrity and compliance with all applicable global and regional guidelines and regulations, ICH-GCP guidelines and SOPs.
Key Responsibilities.
- Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Clinical Operations Director.
- Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
- Support the Clinical Operations teams with ongoing conduct of studies.
- Very Knowledgeable with applicable ICH GCP, and DIA TMF requirements.
- Ability to develop or use existing tracking tools.
- Proficiency in office suite and particularly Microsoft Excel and PowerPoint.
- Familiar with various roles within clinical operations, such as a CRA role and PM.
- Assist project teams with study specific documentation and guidelines as appropriate.
- Set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
- Assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
- Assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
- Asist in co-ordination of Investigator payments, if applicable.
- Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc. when requested).
- Maintain the Training Matrix and training forms.
- Submit system requests for the Clinical Operations teams and vendor representatives when applicable.
- Conduct initial submission QC in Veeva Vault and assist in completing quarterly QC of the eTMF.
- Complete study metric trackers and reports.
- Assist in the tracking and distribution of safety reports.
- Co-ordinate document translation, if required.
- Attend team meetings and generate meeting agenda’s and minutes when needed.
- Assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
- Assist in the production of slides, etc., as needed for project, departmental, and/or business development presentations.
- Assist with the coordination of team member tracking.
- Other duties may be assigned as required.
Requirements
Experience
- 2-3 years experience as a CTA in either pharmaceutical/biotech
- Experience in clinical study execution
- Experience in cell therapy
- Experience in solid tumour studies
- Experience in managing several studies/programs
- Expertise in Veeva
- Proficiency with Microsoft Office Suite and DocuSign
- Experience in performing inspection readiness activities
- Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Excellent oral and written communication, organizational and planning skills
- Willingness to travel as needed
Qualifications
- Bachelor’s degree (BSc, BA or RN equivalent) in a biological or science-related field is essen