RASSU Coordinator

CTI Clinical Trial and Consulting Services; Lisboa; Presencial; EUR 18 000 - 24 000; Tempo integral

Resumo da oferta

CTI Clinical Trial and Consulting Services seeks a Regulatory Affairs Administrative Assistant to support document compilation and submissions for clinical trials in Lisbon. You will assist local study teams, ensure document quality in the study start‑up module and eTMF, and help manage tracking reports and translation workflows.

The role requires German and English language skills at C1, strong organizational ability, and the capacity to handle multiple tasks independently while using Microsoft

Qualificações

• 1 year of research or regulatory experience.
• Sound basic knowledge of medical and pharmaceutical terminology.
• Understanding of the drug development and clinical trial process.
• Experience using Microsoft tools to edit, reformat, and finalize regulatory documents.
• Bachelor’s Degree in allied health fields such as nursing, pharmacy, or health/natural science.

Responsabilidades

• Assist in compilation and revision of RA documents for clinical trials submissions.
• Assist with contact to local study teams for RA documents collection and checks.
• Assist in obtaining maintenance documents from sites during the trial.
• Assist in quality checks of documents in the study start‑up module and eTMF.
• Assist in SUSARs submission package preparation to ethics committees where applicable.
• Provide backup support for RA activities and trainings as needed.
• Attend weekly team meetings and assist in preparing agendas and minutes.

Conhecimentos

German (C1)

English (C1)

Excellent communication

Organizational skills

Independent worker

Multitasking

Computer skills

Microsoft Office

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

Responsibilities

• Assist in compilation and revision of Regulatory Affairs (RA) documents required for clinical trials submissions
• Assist in contact with local study teams for RA documents collection and checks, when applicable
• 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 (initial submissions, substantial amendments, and non‑substantial amendments) 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

What You'll Bring

• Excellent verbal and written communication skills
• Excellent command of German and English language (verbal and written) – Language skills at level C1 are mandatory
• Excellent organizational and record retention skills
• Excellent interpersonal skills
• Strong computer skills
• Ability to work independently
• Ability to handle multiple tasks and manage time efficiently

Required Education and Experience

• 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