Clinical Trial Administrator

*** Please Note - this is an internal vacancy only. We will not be accepting applications from external candidates at this time ***

Job purpose: 
As a CTA you will work within the Research Support Team, working closely with the 
Community Research Team and Business Delivery Managers to provide a central support role 
to facilitate, safe and participant focused clinical research. 
You must fully understand and ensure your personal responsibility for patient safety and the 
integrity of any patient data collected during the study. You will collaborate with clinical 
investigators and sponsor companies to manage trial protocols to ensure high quality 
research.  
The nature of the work is unpredictable, and you will be expected to be flexible and 
responsive in order to manage various aspects of the job at short notice. You will be expected 
to participate fully in your own personal development. 

Key Accountabilities:

• Set up and maintains study specific databases.


• Set up and maintains clinical trial-related trackers such as regulatory documents and 
  Trial Master File (TMF) in accordance with ICH GCP and study specific SOPs and as per 
  Project Manager/Sponsor instructions.


• Develop strategies for ensuring complete and accurate delivery of research related 
  data, management of studies and documentation.  


• Archiving of paper and electronic data as required. 


• Carry out regular quality control checks of trackers, ISF’s, site management 
  information as required. 

Responsibilities

• Liaise with Clients and Vendors as required to fulfil role.


• Provide weekly reports on role specific tasks and progress against study deliverables.  


• Support coordination of weekly reports and study metrics for internal and client review.


• To contact clinical sites for specific requests (e.g. enrolment updates, missing 
  documentation, meeting arrangements, etc).


• To be familiar with ICH GCP, appropriate regulations, relevant NWEH SOPs and internal 
  tracking systems.


• Ensure familiarity with risk issues pertaining to confidentiality of participant and 
  research related documentation (General Data Protection Regulation 2018 and Caldicott 
  Review 2013).


• Support and execute all activities in line with ISO standards where relevant (ISO 
  9001:2015).


• Work collaboratively with multiple stake holders to ensure timely resolution of data 
  queries.


• Ensure compliance with NWEH and local policies/guidelines and Standard Operating 
  Procedures (SOPs) to ensure all procedures are followed correctly.


• Identify any study related issues or non-conformance and escalate within specified 
  timelines.


• To assist the project teams with study specific documentation and guidelines as 
  appropriate.


• To set up, organise and maintain clinical study documentation including preparation for 
  quality control audits, internal/external audits, final reconciliation and archival.


• To attend project meetings.


• Perform other duties as assigned by management. 

Person Specification: 
Essential: 

• Research documentation management experience.


• Proficiency in Adobe Acrobat Professional (or similar) tools and web-based document 
  indexing and viewing application.


• Computer skills including high level of proficiency in the use of Excel, PowerPoint and 
  Microsoft Word.


• Good organisational skills, ability to manage multiple sites and meticulous attention to 
  detail.


• Evidence of working and managing relationships within a Pharmaceutical or CRO 
  company.


• Self-motivated, positive attitude with good oral, written communication and 
  interpersonal skills.


• Flexible approach to working.


• Committed to self-development and able to demonstrate professional development.


• Ability to organise own work and meet deadlines.


• Willingness to work within a multi-disciplinary team, working autonomously and as a 
  team player.


• Experience applicable to clinical research including clinical development phases and 
  process including HRA and ethics regulatory processes.

Desirable

•  Ability to demonstrate an understanding of the issues surrounding clinical data, 
  particularly confidentiality & safety monitoring.


• Knowledge of NHS Research and Development, the pharmaceutical industry and 
  relevant information sciences.


• Knowledge of ethical and quality standards applicable to clinical trials including EU 
  directives and on ICH GCP requirements.