Careers

TITLE: Clinical Trial Administrator

Clinical Trials Administrator

Key Requirements

  1. 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.
  • 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

  1. Science and/or medical or nursing background.
  2. Previous Medical or Clinical Research experience.
  3. 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