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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Trial Associate


Reference:SCA013783 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor, Clinical Trials Assistant

Clinical Trial Associate

Our client, a pharmaceutical company based in are currently recruiting for a Clinical Trial Associate to join their team on a permanent basis. Your responsibilities will include assisting in the execution and management of clinical research projects. You will be well-versed in clinical trial management and have experience covering the therapeutic area of Gastrointestinal (GI) diseases and/or Oncology. This role is hybrid working.

Responsibilities

  • Assist the Clinical Project Manager and Clinical operations team in managing and overseeing the execution of multiple phase I to IV clinical trials sponsored orfinanced by the Company to ICH-GCP standards
  • Review and analysing clinical trial data and other metrics for accuracy, data integrity and completeness
  • Manage contract research organization (CRO) and other external vendors supportingclinical studies
  • Manage set-up and regular study meetings with vendors responsible for clinical trialdeliverables and data quality providing oversight of the CRO monitoring activities processes, monitoring visits planning review of the monitoring visit reports, CRA activity and site documents
  • Support with study invoices verification and approval
  • Contribute to the development of study related documents (contracts, informed consent, protocols, Investigator Brochure, study plans, regulatory submissions for Scientific Advice etc.)
  • Participate in development of Case Report Form (CRF) and the design and testing of clinical data base
  • Assist during study feasibility with investigators identification and selection and travel to clinical trial sites (global locations) for study engagement and, if necessary, assess ICH-GCP and protocol compliance and oversee clinical trial monitoring activities and data quality
  • Perform quality controls of the study TMFs and any other duties as may be reasonably required from time to time
Requirements
  • A bachelor’s degree in the life sciences will ensure your familiarity with regulatory guidelines and clinical terminology
  • 2 years’ experience working in clinical trials as CRA with strong working knowledge ofthe clinical research process
  • Experience in using eCRF systems, eTMF and CTMS
  • Experience in ICH-GCP audits/Inspections is an advantage
  • Willingness to perform additional tasks under supervision, which will be part of the internal professional development
  • Soft skills: proactive attitude, flexibility, problem solving, goal orientation, time management and organization
  • Problem solving and negotiating skills

For more information please contact Sinéad Cullen on +353879500821 or [email protected]