ABOUT US

At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.

 

OUR COMPANY

Quell was founded in March 2019 in partnership with six prominent immunological experts from King’s College London, University College London, and Hannover Medical School, and is led by Iain McGill, a leading pharmaceutical executive with extensive relevant experience, having spent most of his 25 years in the industry in immunology, including the areas of solid organ and cell transplantation. The Company was founded with initial series A financing, led by Syncona Ltd who committed £59M with a further £2M contributed by UCL Technology Fund.

 

THE ROLE

Clinical Trial Associate (CTA) / Senior Clinical Trial Associate (Sr. CTA)

The Clinical Trial Associate (CTA) / Senior Clinical Trial Associate (Sr. CTA) supports clinical studies and the Clinical Operations Department, in managing various administrative tasks such as generation of agenda and minutes, maintaining study tracking, filing and quality reviews as well as participating to process improvement initiatives across the departments. This position will report to the Director of Clinical Operations. The CTA / Sr. CTA will play a key role in working cross functionally to support the clinical teams including close collaboration with study team from vendors/CROs in completing all required tasks to meet departmental and project goals.

 

The incumbent will adhere to Quell values and work in compliance with all applicable regulations, guidelines notably ICH-GCP guidelines and SOPs. Strong candidates will bring knowledge and experience in the fundamental aspects of trial and study site management, vendor management, and experience in the full cycle of study from start-up to close out.

 

MAIN RESPONSIBILITIES

• Provide general administrative support to the Clinical Operations Department and assistance to Clinical Project Manager(s).
• Assist in the production of presentations as needed for project, departmental, and/or business development.
• Assists the Clinical Project Manager (CPM) with Sponsor oversight, study specific documentation review and QC including review of ICF, study plans, study reference manuals, eCRF, etc.
• Assist with creation and maintenance of study metrics trackers, tools and reports.
• Asist in co-ordination and tracking of Investigator and third-party payments.
• Ensures required study documents are submitted to the CRO-held eTMF.
• Assists the CPM with Sponsor oversight of CRO-held eTMFs periodic audit and findings resolution.
• Assist the CPM in executing clinical monitoring oversight.
• Assists with customisation of CDA, clinical site contracts & budgets, when applicable.
• Assist the CPM and clinical team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
• Co-ordinate document translation, if required.
• May participate in training CRO teams and in the onboarding of new CRO team members.
• May contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc. when requested).
• Attends internal and external team meetings/teleconferences and generate meeting agenda and minutes when needed.
• Other duties may be assigned as required.
• Willingness to travel as needed (<5%). Currently, all work-related travel is on hold. Travel will only be required once travel activities can safely resume.

 

EXPERIENCE WE ARE LOOKING FOR

• Experience and knowledge of ICH GCP, eTMF management and DIA TMF Reference Model.
• Previous CTA experience working with CROs and vendors.
• Experience of working effectively in a fast-paced team environment.
• Bachelor’s degree (BSc, BA or RN equivalent) in a biological or science-related field is essential.

 

TECHNICAL SKILLS REQUIRED

• Proficiency in office suite notably Microsoft Excel and PowerPoint.
• Ability to develop and/or use existing tools (e.g. tracking tool).
• Experience of working across functions.

 

PERSONAL QUALITIES

• Excellent organisational, interpersonal and communication skills
• Ability to prioritise and manage multiple tasks.
• Desire to work with integrity and act as an ambassador for Quell and the wider business.

 

BENEFITS

• Holidays: 25 days per year
• Life Assurance: 4 x base salary
• Group Personal Pension: Auto enrolled at 4% employer contribution, 4% employee contribution
• Private Medical Insurance for your whole family
• Annual Bonus

 

PERKS

• Fantastic collaborative environment at Translation & Innovation Hub – Click here for Virtual Tour
• £61 Million Investment including brand new lab equipment, innovative methods, and exposure to cutting edge technology
• Flexible working
• Fast paced and progressive company looking for future leaders and innovators