Clinical Trial Administrator

The Clinical Trial Administrator is responsible for the administration and co-ordination of the procedural aspects of Complement Therapeutics clinical trials and the filing and subsequent archiving of clinical trial documentation. The Clinical Trial Administrator will get the opportunity to get involved in various tasks which will help develop the understanding of all phases of the study lifecycle: initiation, start-up, recruitment, maintenance and close-out.

Responsibilities:

• To provide administrative support to the Clinical Team by assisting the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation in order that it is organised and ready for inspection at all times.
• To assist the Clinical Team in their roles
• Scheduling and attending internal study calls and taking minutes/action items as needed
• Attending regular and ad-hoc calls with CROs/Vendors
• Attending study team meetings in person (minimal travel is expected)
• Contributing to development and review of study documents: forms, templates and plans (depending on experience)
• Assisting with development of study/program specific ISF and related documents
• Coordinating shipment of study supplies to sites
• Finding and approaching new vendors based on study set up and requirements.
• Requesting and reviewing vendors` proposals; reporting to the study team
• Maintaining study spreadsheets as necessary to facilitate tracking/documentation of study status
• Providing support to Regulatory Affairs and Quality Assurance on an as needed basis

Qualifications and Experience

• Minimum 2+ years of experience in a similar role supporting the study team
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines 
• Prior exposure to and understanding of international trial set up
• Understanding of different phases of the trial, ideally from study initiation to closeout
• Systematically perform activities in a timely and accurate manner
• Work precisely according to procedures, rules and regulations whilst being flexible and open to change
• Comfortable with juggling multiple tasks and priorities
• Able to work independently within their own role and with minimum supervision from the study team
• Able to communicate clearly and in a concise manner, both verbally and in writing 
• Team player
• Does not shy away from challenges 
• Demonstrates a lot of initiative and can-do attitude 
• Creative solution finder with ability to think ahead 
• Fast learner
• Good attention to detail
• Familiar with and confident with use of MS Office applications: Word, Excel & Powerpoint

If this role sounds interesting, please apply using the link below : https://bit.ly/3CYGwbK