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Principal Scientist
Dublin South
QA Manager
Dublin West
QA Specialist
Dublin West
Head of Quality
Dublin West
Snr Process Engineer
Dublin North
R&D Engineer
Galway
QA Manager
Meath
Snr QA Specialist
Dublin South
Qualified Person
Dublin West
QA Director
Dublin North
Program Manager
Westmeath
Market Access Manager
Dublin City Centre
Technical Sales Engineer
Republic of Ireland
Senior Chemist
Dublin North
QA Manager Biologics
Dublin West
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Search Results for Clinical Research Associate
Job Title. Location Salary Actions

Clinical Research Specialist

Our client based in Limerick is creating innovative technological solutions to manage clinical trials. A background within Clinical Trials / Clinical Data / Clinical Nursing is essential. Their unique environment and culture will attract you if you’re: • Passionate about clinical research • Eager to make trials easier for everyone involved • Excited at the prospect of working on a new and creative approach to trials Responsibilities: • Act as the clinical trial advisor and expert on a multidisciplinary team. • Wor...

Location: Limerick,
Clinical Research Specialist
Limerick 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