RASSU Coordinator

Consulting, Inc.; Lisboa; Presencial; EUR 17 000 - 26 000; Tempo integral

Resumo da oferta

Consulting, Inc. in Lisbon, Portugal, seeks an Administrative/Regulatory Affairs assistant to support RA documents for clinical trials.

You will liaise with local study teams and sites to collect and verify documentation, help in TMF and BI reporting, and assist in regulatory submissions in compliance with country requirements. The role requires at least 1 year in regulatory or research-related work, and strong German and English language skills (C1).

Qualificações

• Minimum 1 year of research or regulatory experience.
• Good knowledge of medical and pharmaceutical terminology.
• Understanding of drug development and clinical trial processes.

Responsabilidades

• Assist in compilation and revision of Regulatory Affairs documents for clinical trials submissions.
• Assist in contacting local study teams for RA documents collection and checks.
• Assist in contacting sites to obtain maintenance documents during the trial.
• Assist in quality checks of documents in the study start up module and the eTMF.
• Assist in pulling expiration 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 BI report tracking.
• Assist in preparing study submission packages (Initial Submissions, Amendments) to Ethics and Regulatory Bodies as required.
• Arrange shipments of regulatory documents; track and retrieve items.
• Assist in document translations when applicable.
• Assist in SUSARs submission package prep to Ethics Committees.
• Assist in completing trackers and applying naming conventions in TMF systems.
• Provide backup support for RA activities and general administrative tasks.
• Participate in trainings and help develop project-specific Work Instructions.

Conhecimentos

Verbal and written communication

German and English proficiency (C1)

Organizational and retention skills

Interpersonal skills

Independent work ethic

Multitasking and time management

Formação académica

Bachelor's degree in allied health fields (nursing, pharmacy, health/science)

Ferramentas

Microsoft Office

Descrição da oferta de emprego

• Assist in compilation and revision of Regulatory Affairs (RA) documents required for clinical trials submissions
• Assist in the 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 is 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 the 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 on level C1 are mandatory
• Excellent organizational and record retention skills
• Excellent interpersonal 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 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