Clinical Trial Assistant (Hybrid / Luton)

Our sponsor dedicated (cFSP) team are seeking a CTA to join us on our mission to drive healthcare forward.

Hybrid working on offer, with 2-3 days per week required on-site in Luton with the sponsor; a global biopharmaceutical.

The CTA will perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files and completeness.
• Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Act as a mentor for less experienced Clinical Trial Assistants (CTAs).
• Assist with training and onboarding of new CTAs.
• May serve as subject matter expert for business processes.
• May lead CTA study teams.
• May assist with interviewing and screening of potential new team members
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
• May participate in departmental quality or process improvement initiatives.

• Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
• Minimum 6 months clinical research experience strongly preferred.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
• Effective written and verbal communication skills including good command of English language.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Learn more at https://jobs.iqvia.com