administrator
Responsibility
- provide general administrative support to the Study Operations Team, including the Study Manager and Study Lead, to meet project goals
- build and maintain a relationship with local Clinical Research Networks
- lead site engagement, feasibility, selection, set-up, initiation, and close-out activities
Show more +11 - provide extensive study site support by answering study-specific questions and resolving issues occurring at sites, and conduct site visits where necessary
- coordinate the site contract process, including drafting and sending out contracts for signature
- coordinate site invoicing
- contact sites for specific requests
- working with the Study Operations Team, ensure the study is delivered according to the requirements of the protocol, and within study budgets and timelines
- conduct and report on remote and centralised monitoring, and implement follow-up actions
- assist with site audit preparation
- conduct quarterly quality and completeness reviews of the TMF and ISF
- develop site training materials, and site- and participant-facing materials
- track and respond to study participant queries
- coordinate the sample management process, including procurement of consumables, and tracking of sample shipments and processing at the lab
Requirements
- A bachelor’s degree in a biological or science-related field; or
- equivalent experience or qualifications in a relevant field
- knowledge of the regulatory environment for conducting research studies
Show more +4 - knowledge of ICH GCP and GDPR
- excellent communication skills and ability to deal with difficult or pressured situations and to work on a number of projects simultaneously
- ability to work competently, manage own workload and time efficiently to tight deadlines, and to troubleshoot problems without continuous supervision
- detail-oriented and highly organised with the ability to ensure accuracy and rigour in all areas of work
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