Key Requirements
High proficiency in Microsoft Office and the ability to quickly learn new software systems.
Proven organisational and time-management skills with a high degree of attention to detail.
A foundational understanding of the clinical trial process is a strong advantage.
A third-level qualification in a life science, nursing, or related discipline.
Main Functions
To carry out administrative duties on assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures.
To provide additional administrative support to Clinical Operations and other Departments and office where required.
Primary Responsibilities may include
1. Trial-Specific Administrative Support:
Serve as the administrator for the Trial Master File (TMF), including its preparation, maintenance, filing, and archiving under the direction of Project Management.
Prepare and maintain Investigator Site Files (ISFs) and Pharmacy Files.
Coordinate the collection, tracking, and filing of essential and site-level documents.
Prepare and collate study documents for distribution to hospital sites and sponsors.
Assist in ordering, tracking, and management of clinical trial supplies.
Process study participant registrations and assist with the logistics for bio-sample shipments.
2. System & Data Management Support
Provide administrative support for key clinical systems (e.g., CTMS) as required.
Assist the Data Management team with collation and tracking of Case Report Forms (CRFs).
Maintain office databases and trackers as requested by the Line Manager.
3. General Office & Team Support
Organise meetings (including DSSG meetings and conferences), prepare agendas, and take minutes.
Handle general office tasks, including managing the main reception phone, booking meeting rooms, ordering office supplies, and managing the 'info@' mailbox as needed.
Assist with training administration and preparations for training courses.
Support general office archiving activities.
Assist with Cancer Trials Ireland membership requests; assist in update and maintenance of Cancer Trials Ireland membership details.
Input into SOP development where appropriate.
Contribute to preparation for audits and inspections as required.
Perform other tasks as assigned.
#J-*****-Ljbffr