Key Requirements1. Full working knowledge of and competence with Microsoft Office.2. Proven organisational skills.3. Working knowledge of clinical trial process an advantage.4. Science or nursing qualification
Main Function(s)
• 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 Department and office where required.
Primary Responsibilities may include
• Preparation of Trial Master Files and Investigator Site and Pharmacy Files, including printing, filing, and tracking of clinical trial documents.
• Serving as administrator of the Trial Master File with direction from Project Management, including the preparation, maintenance, and archiving of the TMF.
• Coordinate the preparation, collection, tracking and filing of essential documents including centralised documents (Investigator/ investigational site staff CVs, Investigator Agreements, GCP certificates, laboratory accreditation, etc.)
• Preparation of site-specific study documents, including patient related documents under the guidance of the Clinical study team.
• Collating and sending clinical trial documents to hospital sites and Sponsor. Ordering and tracking of clinical trial supplies and investigational product.
• Assist in the logistics for bio-sample shipments.
• Processing study subject registrations for Cancer Trials Ireland studies.
• Responsible for main reception phone, stationary supply and other office tasks as part of the office administration team.
• Coordinate queries and direct issues to appropriate clinical research personnel.
• Assist Data Management with collation and tracking of Case Report Forms (CRFs), including generation of specific Data Management reports.
• Organise meetings, prepare agendas and minutes.