TITLE: Clinical Trial Administrator
Clinical Trials Administrator
Key Requirements
- Full working knowledge of and competence with Microsoft Office.
- Proven organisational skills.
- Working knowledge of clinical trial process an advantage.
- 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.
- Assist with training administration and preparations for training courses.
- Handle 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.
Skills:
Good clinical practices, Science degree, Organisational Skills, Microsoft, Excel
TITLE: Clinical Trial Coordinator
Key Requirements
- Science and/or medical or nursing background.
- Previous Medical or Clinical Research experience.
- Proven ability to deliver project goals and mentor junior level employees.
Main Function(s)
- Maintain knowledge and ensure compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs (Standard Operating Procedures), study protocols and project-specific procedures.
- Coordination of clinical trial activities for assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, study protocols and study-specific procedures, Cancer Trials Ireland SOPs and/or other Sponsor SOPs if applicable.
- Develop and maintain strong working relationships with external stakeholders/Sponsors.
Primary Responsibilities
- Manage and coordinate assigned studies, including development of country specific documents and overseeing regulatory and ethic committee applications.
- Primary contact for Sponsor and collaborator groups for assigned studies.
- Manage project-specific training and mentoring.
- Contribute to preparation for audits and inspections as required.
- Evaluate and document investigator and site selection as applicable.
- Overall responsibility for management of essential documents and Trial Master File where applicable.
- Responsible for the completion of study initiation, monitoring and close-out as required by the study.
- Identify issues and manage the resolution process for studies under their coordination.
- Ensure compliance with all applicable Cancer Trials Ireland and/or other Sponsor SOPs if applicable for all studies under their coordination.
- Input in SOP development and updates where appropriate.
- Ensure budget agreements and contracts are in place and roles and responsibilities documented prior to commencing study activities.
- Manage the study budget and associated financial activities for assigned studies where applicable.
- Organise, participate in and present at meetings and discussions with other teams and team members.
- Update Head of Clinical Operations and Project Manager where applicable for assigned studies on the status of all clinical trial activities.
- Prepare study reports as required.
- Perform other tasks as specified by Line Manager
If you are interested in any of these positions, please apply on irishjobs.ie or directly to Ide Fagan @ ide.fagan@cancertrials.ie