RASSU Regulatory Coordinator: Trials Docs

Cti Clinical Trial And Consulting Services; Almada; Presencial; EUR 18 000 - 24 000; Tempo integral

Resumo da oferta

Cti Clinical Trial And Consulting Services is seeking a Regulatory Affairs Administrative Assistant for Setúbal/Almada, Portugal. You will support the preparation, revision, and submission of regulatory documents for clinical trials, coordinate with local study teams, and help maintain study start-up records and eTMF.

The ideal candidate will have at least 1 year of regulatory or research experience, strong German and English skills (C1), and proficient use of Microsoft tools to edit and

Qualificações

• At least 1 year of research related experience and/or regulatory experience.
• Experience providing sound basic knowledge of medical and pharmaceutical terminology
• Experience providing a good understanding of the drug development and clinical trial process
• Experience in using Microsoft tools to edit, reformat, and finalize legal regulatory documents
• Bachelor's Degree in allied health fields such as nursing, pharmacy, or health/natural science

Responsabilidades

• Assist in compilation and revision of Regulatory Affairs (RA) documents for clinical trials submissions
• Assist in contacting sites to obtain maintenance documents throughout the trial
• Assist in quality checks of documents in the study start-up module and the eTMF
• Assist in pulling expiration reports and reconciliation reports
• Assist in managing the RASSU SharePoint
• Maintain resourcing tracker for staff assignments and future awarded work
• Assist in preparing site timelines for IRB reviews presented in Bid Defenses
• Assist in Business Intelligence (BI) report tracking
• Assist in preparation of study submission packages to Ethics and Regulatory Bodies, according to countries requirements
• Arrange for shipments of regulatory documents and packages, track and retrieve items
• Assist in the management of the documents to be translated, when applicable
• Assist in SUSARs submission package preparation to Central and Local Ethics Committees in applicable countries
• Assist in the preparation and completion of specific trackers
• Assist in applying naming conventions, upload study documentation in the study start-up module or trackers and study-specific TMF system whether electronic or paper
• provide backup support for RA activities, as needed
• Provide any other administrative support to RASSU team members
• Participate in relevant trainings
• Assist in development of project specific Work Instructions
• Update RASSU specialists and Directors on outstanding items, and issues as they arise
• Attend weekly team meetings, prepare and distribute agendas, prepare and distribute meeting minutes, if requested

Conhecimentos

German (C1)

English (C1)

Verbal & written communication

Organizational skills

Interpersonal skills

Independent work

Time management

Formação académica

Bachelor's Degree in allied health fields such as nursing, pharmacy, or health/natural science

Ferramentas

Microsoft Office

Descrição da oferta de emprego

Cti Clinical Trial And Consulting Services is seeking a Regulatory Affairs Administrative Assistant for Setúbal/Almada, Portugal. You will support the preparation, revision, and submission of regulatory documents for clinical trials, coordinate with local study teams, and help maintain study start-up records and eTMF.

The ideal candidate will have at least 1 year of regulatory or research experience, strong German and English skills (C1), and proficient use of Microsoft tools to edit and