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

Clinical Research Associate (CRA)

Clinical Research Associate (CRA) Our client a Clinical Research Organisation are currently recruiting for a CRA to join their team for a 1-year fixed term contract. As CRA you will monitor sites throughout Ireland, have at least 2 years oncology monitoringexperience and ideally be available for an immediate start. When not travelling to sites, you can work from home. Responsibilities Conduct site visits, including pre-study, initiation, monitoring and termination Confirmadherence to all FDA, ICH-GCP and local regulations Ensure the...

Location: Republic of Ireland,
Clinical Research Associate (CRA)
Republic of Ireland Not Disclosed

Contract & Budgets Trial Capabilities Associate Fluent German

Contract & Budgets Trial Capabilities Associate Fluent German Our client, a global pharma company based in Cork, are currently recruiting for a Fluent German speaking Contracts and Budgets Trial Capabilities Associate to join their team on a permanent basis. As Contracts & Budgets Associate you will be responsible for overseeing specific clinical contract activities, including providing contract process guidance, conducting contract negotiations, conducting contract analyses, facilitating compliance, and pursuing contracting process improvements. ...

Location: Cork,
Contract & Budgets Trial Capabilities Associate Fluent German
Cork Not Disclosed
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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