Opening For Clinical Trials Assistant (CTA) : Cambridge

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Amar Annamalai
Amar Annamalai's picture
Opening For Clinical Trials Assistant (CTA) : Cambridge

 This is opportunity to utilise your experience in clinical trials to help progress some of most innovative therapeutics in the industry. You will have responsibility for supporting Clinical Operation Team members with the tasks associated with implementation and conduct of clinical studies.
 
Overview
 
The position will manage multiple tasks and have responsibility of the eTMF documentation, as well as act as the documentation expert, train staff and support the clinical operation team with study management.
 
Core responsibilities are:
 
• Maintain trial master file (or eTMF), study site records and files and ensure compliance with applicable SOPs
• Training and leadership of Cambridge staff on TMF related activities
• Act as an internal expert on study related documents, procedures and templates
• Collation, filing, routing coordination of third-party provider documents for the TMF/eTMF
• Create, implement, and maintain systems to track study metrics and general information (ex. OPAL and IMPACT, etc.)
Coordinate generation of study metric reports and action logs
• Initiate contract/budget requests, coordination and management of contract approvals, and tracking ongoing status 
• Schedule team meetings and prepare agendas and minutes of complex clinical meetings 
• Prepare and distribute study-related correspondence to clinical vendors and sites as required
• Conduct basic data quality oversight activities associated with clinical vendors.
• Assist clinical operations team with study management
• Participate in ongoing vendor management. Oversee CTA level staff at CROs to ensure compliance to tracking, TMF/eTMF management and other requirements.
 
Your previous experience will:
 
Demonstrate management of paper and/or eTMF documentation within a pharmaceutical, biotech or CRO background. You must demonstrate a strong understanding of clinical trial documentation and GCP requirements. In addition you must have the ability to coordinate and prioritise multiple clinical trial related tasks, including provision of complex meeting minutes. 
• Clinical trial experience and coupled with time working in an office environment in a CRO, biotech or pharmaceutical company. CRA experience would be considered an advantage.
• Understanding of ICH, GCP and relevant regulatory requirements.
 
Education:
 
• Bachelor’s Science Degree or nursing qualification is preferred.
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