Clinical Trial Assistant/Administrator (CTA) - England

I am searching for a Clinical Trial Administrator in the UK/Surrey area. There has been recent growth and change in the business which has resulted in the company looking to expand in the UK, U.S and Europe. The company mainly specialises in the rare disease field so take on complex trials with small to mid-sized biotech clients and are highly patient-centric.
Q1/Q2 proposals have gone well meaning there is lots of new business coming and career development opportunities. Also, they are advocates for flexibility and work-life balance, but of course are looking for people to roll their sleeves up and work hard.

The primary purpose of the Clinical Trials Administrator (CTA) is to administer, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs).  They also act as a pivotal point of contact & support for the clinical trial team.

Major Activities – Include but may vary.

The CTA will be involved in most activities in preparation for study set up, conduct and completing a Clinical Trial which usually includes:

• Arranging & participating in the organisation of Investigator Meetings & Study Team Meetings, taking minutes & distributing.
• Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
• Prepare for the distribution of protocols, Investigator Brochures and CRFs, including keeping track of and re-ordering supplies.
• Set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (ISF)
• Managing and maintaining study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites.
• Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.
• Create & maintain study contact lists for team/sites/3rd parties/set up mail merges.
• Sending out Study Correspondence to all participating sites on an ongoing basis.
• Setting up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments.
• Diary management for the clinical trials team
• Coordinating archiving of study documentation
• Assist with Data Cleaning activities
• Arranging translation of patient documents
• Maintain understanding of Good Clinical Practice
• Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.

Key Performance Indicators

• Ensuring the Trial Master Files are appropriately maintained
• Ensuring tracking systems for trial related paperwork always remain up to date

Key Job Competencies

• Understanding of clinical trial processes and needs
• Excellent transferrable skills
• IT literacy, particularly in Word, Excel and PowerPoint 
• Knowledge of ICH GCP
• Good communication skills (written and verbal)
• UK based experience

Job background

• University degree or equivalent in health sciences, nursing or pharmacy or related field
• Minimum 2 years’ experience of working in Clinical Research or the Pharmaceutical Industry
• Knowledge of the Industry/Clinical trial process and drug development
• Experience of administrative support in a busy environment
• Experience of using the eTMF system

For further details on this urgent opportunity please email acoppen@barringtonjames.com