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Search Results for Clinical Research Associate
Job Title. Location Salary Actions

Director Clinical Trial Capabilities

Director Clinical Trial Capabilities Our client, a global pharmaceutical organisation are currently recruiting for a Director of the Clinical Trial Capabilities team. As the Director of Clinical Trials Capabilities you will be accountable for clinical trial capabilities within the Clinical Development Organization. You will lead the regional organization that provides the global clinical trial capabilities in support of global clinical development which includes site activation/management/closeout, site contracting, clinical finance, records management, training, and trial...

Location: Cork,
Director Clinical Trial Capabilities
Cork Not Disclosed

Clinical Trial Associate German Speaking (based in Ireland)

Clinical Trial Associate German Speaking (based in Ireland) Our Cork based client are currently recruiting for an experienced fluent German speaking Clinical

Location: Cork,
Clinical Trial Associate German Speaking (based in Ireland)
Cork Not Disclosed

Senior Manager Trial Capabilities

Senior Manager Trial Capabilities Our client, a global pharmaceutical organisation are currently recruiting a Senior Manager to join their newly created Clinical Trials Capabilities team. As Senior Manager you will lead the clinical trial capabilities in support of clinical development. This is an exciting opportunity which will allow you to provide leadership, direction and technical support to the Clinical Trial Capabilities Teams focusing on results and driving efficiency to achieve goals and objectives Responsibilities: • Accountable for meeting and exceeding goals ...

Location: Cork,
Senior Manager Trial Capabilities
Cork Not Disclosed
Other Clinical Research Jobs
Job Title Location Salary Actions
NPD Project Manager (Healthcare) Dublin Not Disclosed
Budgets and Contracting Clinical Trial Associate Cork Not Disclosed

Clinical Research Associate Career Profile

Clinical Research Associate

The Clinical Research Associate is tasked with monitoring clinical trials sites in order to ensure that studies are carried in accordance with the study protocol, the company standard operating procedures (SOP), applicable regulations and the principles of ICH - GCP (International Conference on Harmonisation - Good Clinical Practice).

Key Responsibilities

  • Identification of key investigators
  • Assistance in the preparation of regulatory submissions
  • Design patient information sheets and consent forms
  • Coordinate document translation and verification
  • Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements
  • Pre-study and initiation visits
  • Conduct regular monitoring visits in accordance with the trial site monitoring SOP
  • Maintain all files and documentation pertaining to studies
  • Motivate investigators in order to achieve recruitment targets
  • Complete accurate study status reports.
  • Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs
  • Keep the project manager regularly informed
  • Process case record forms to the required quality standards and timelines
  • Ensure the satisfactory close-out of investigator sites
  • Ensure correct archiving of files on completion of a study
  • Co-operate with QA personnel in the conduct of QA audits
  • Participate in feasibility studies for new proposals
  • Maintain patient confidentiality

Qualifications / Experience Required

  • Degree in Life Sciences or Equivalent
  • Ability and willingness to travel at least 50% of the time, both international and local
  • Ability to review and evaluate clinical data
  • Computer literacy desirable
  • Foreign language skills desirable
  • Current full driving license essential
  • Good oral and written communication skills