Job Description

Provide general administrative support to the Study Operations Team, including the Study Manager and Study Lead, to meet project goals.

Working with the Study Operations Team, ensure the study is delivered according to the requirements of the protocol, and within study budgets and timelines.

Build and maintain a relationship with local Clinical Research Networks (CRNs).

Lead site engagement, feasibility, selection, set-up, initiation, and close-out activities.

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 (e.g., missing documents, invoicing)

Conduct and report on remote and centralised monitoring and implement follow-up actions.

Assist with site audit preparation.

Set-up, organise and maintain study documentation, including the trial master file (TMF) and investigator site file (ISF), including preparation for internal/external audits.

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 que

Coordinate the sample management process, including procurement of consumables, and tracking of sample shipments and processing at the lab.

Contribute to regulatory submissions, including protocol amendments, as required.

Participate in study team meetings and create meeting agendas and minutes.

Required Knowledge, Skills, and Abilities

Knowledge of the regulatory environment for conducting research studies

Knowledge of ICH GCP and GDPR

Proficient in MS Office Suite experience - Word, Excel, PowerPoint, Excel

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