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

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

Medical Study Manager

Medical Study Manager Our client, a world class provider of human clinical studies are currently recruiting for a Medical Study Manager to join their team on a permanent basis. As Medical Study Manager you will ensure the safety and wellbeing of the Participants on the clinical trial. The Medical Study Manager be responsible for completing specialised health related assessments and reviewing safety data in accordance with ICH-GCP principles. The successful candidate will be a qualified medical doctor, registered with the IMC and have experience in clinical trials/clinical ...

Location: Cork,
Medical Study Manager
Cork Not Disclosed

Clinical Affairs Manager

Clinical Affairs Manager Our client, a medical device organisation, are currently recruiting for Clinical Affairs Manager to join their team on a permanent basis. As Clinical Affairs Manager you will, lead and participate in clinical project teams as part of the company’s clinical programs. The clinical programs include first in human, pilot, pivotal and post-launch studies. You will manage multiple operational studies, provide oversight throughout the development, implementation and conduct of clinical studies globally, develop study plans an...

Location: Galway,
Clinical Affairs Manager
Galway 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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