Clinical Trial Associate, Cell Therapy
Expiry Date :
Mon, 09 Aug 2021 23:59:59 GMT
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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 personalised 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 organisation, working together to solve novel problems. This entrepreneurial spirit and approach run through our company and those who thrive here are able to 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.
The Clinical Trial Associate (CTA) supports US-based or global studies, in managing the eTMF activities including Quality checks, adhering to integrity and compliance with the FDA regulations, ICH-GCP guidelines and SOPs, as well as the DIA model.
* 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 the 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 requirements.
* Ability to develop or use existing tracking tools
* Proficiency in the 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.
* Assist in the coordination 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.
* Coordinate document translation, if required.
* Attend team meetings and generate meeting 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 the project, departmental, and/or business development presentations.
* Assist with the coordination of team member tracking.
* Other duties as assigned
* 5-8 years experience as a CTA
* Strong experience in cell therapy and solid tumour
* Biotech and Pharma industry experience preferred
* 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
* Thoroughness and dealing with complexity
* Proficiency with Microsoft Office Suite and DocuSign
* Veeva Vault and SharePoint experience
* Willingness to travel as needed
* Bachelors degree (BSc, BA or RN equivalent) in a biological or science-related field is essential
This is a permanent position, based in Philadelphia, with a competitive salary and benefits package