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

Clinical Trial Registry & Transparency Senior Manager

Clinical Trial Registry & Transparency Senior Manager Our global pharma client are continuing to grow their team and are currently recruiting for a Clinical Trail Registry (CTRT) and Transparency Senior Manager. As Clinical Trail Registry (CTRT) and Transparency Senior Manager, you will be responsible for working with cross-functional, multidisciplinary teams to facilitate the delivery of CTRT and Transparency documents and will draw upon information from multiple internal and external sources to lead and provide technical coaching to the CTRT and Transparency writi...

Location: Cork,
Clinical Trial Registry & Transparency Senior Manager
Cork Not Disclosed

Associate Director, Clinical Delivery Program Lead

Associate Director, Clinical Delivery Program Lead Our client, a global pharma company, are continuing to grow their Clinical Development and Operations team and are currently recruiting for an Associate Director Clinical Delivery Program Lead to join their team on a permanent basis. AsAssociate Director Clinical Delivery Program Lead you will be responsible for exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan. Responsibilities: Lea...

Location: Cork,
Associate Director, Clinical Delivery Program Lead
Cork Not Disclosed

Associate Director Clinical Trial Capabilities

Associate Director Clinical Trial Capabilities Our client, a global pharmaceutical organisation are currently recruiting an Associate Director to join their Clinical Trials Capabilities team on a permanent basis. As Associate Director 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: Lead and co...

Location: Cork,
Associate Director Clinical Trial Capabilities
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

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