Clinical Research Associate

PE Global
14 Jun 2019
24 Jun 2019
Contract Type
Full Time
The Role
A Clinical Research Associate for a US Multinational Company required for a 12 month contract in Inverness, Scotland.
  • Plan & implement a programme of monitoring for all international regulatory and other clinical research studies and maintain the highest ethical, clinical and scientific standards ensuring both the safety and well-being of all trial participants, and good/rigorous scientific practice.
  • Provide support to Clinical Operations for agreed projects by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.
  • Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well-being of all trial participants and good/rigorous scientific practice.
  • Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions or amendments for the approval of clinical investigations to regulatory authorities and ethics committees.
  • Assist in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.
  • Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
  • Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
  • Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Operations team management.
  • Maintain compliance with Company SOPs.
  • Maintain a high standard of housekeeping and filing accuracy.
  • Successful planning and execution of monitoring of clinical research projects has a direct bearing on present and future profitability and the maintenance of good relationships with key customers. Accountable for ensuring that the Company's legal and ethical standards of Good Clinical Practice and the Helsinki declaration are maintained in respect of clinical research studies.
Education and Experience
  • 1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
  • 1-2 years (senior 3-4 years) experience of clinical trials management in a medical company preferably with medical devices.
  • Knowledge of clinical study design and management. Relevant experience in implementation of clinical research studies. Working knowledge of international regulatory requirements applicable to clinical research. Awareness of research ethics. Above average oral, written and communication skills.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Ciara on or alternatively send an up to date CV

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