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Clinical Research Assistant

3 mesi fa

Florence, Toscana, Italia ManpowerGroup A tempo pieno

ManpowerGroup is seeking a Scientific Assistant to join a prominent pharmaceutical organization. The successful candidate will be integrated into the Clinical Science division, which is part of the Research and Development sector.

Role Overview:

The Scientific Assistant will play a crucial role in supporting various project-related activities, ensuring compliance with established protocols and contributing to the overall success of clinical studies.

Key Responsibilities:

  • Assist in the organization and upkeep of project-specific study documentation and files, adhering to Standard Operating Procedures (SOPs).
  • Support the project team in areas such as Data Management, Statistics, DMPK, and Clinical Pharmacology.
  • Facilitate the creation and maintenance of both electronic and physical study documentation.
  • Ensure proper filing and storage of study-related materials, maintaining compliance with SOPs and study-specific procedures.
  • Provide assistance in site activation processes and manage Case Report Form/Query processing.
  • Conduct Quality Reviews to identify and address any discrepancies.
  • Complete and submit weekly project timesheets in accordance with company guidelines.
  • Perform additional tasks as assigned by management that are relevant to the role.
  • Assist in the establishment and oversight of contracts with external vendors, ensuring adherence to company policies, including managing purchase orders and invoices.
  • Support the preparation of documentation necessary for customs clearance of biological samples from clinical trials.
  • Assist in the development of files for budgeting and forecasting, as well as managing accruals.
  • Provide support in the management of internal technology systems, including software acquisition and license renewals.

Qualifications:
Applicants should possess a Scientific Degree and have a minimum of 2 years of relevant experience. Proficiency in English and MS Office (Word, Excel, PowerPoint) is required. General office skills, including filing, faxing, copying, and archiving, are essential. A solid understanding of ICH/GCP Guidelines concerning data quality and the conduct of clinical trials is also necessary.