Clinical Research Compliance Expert

4 semanas atrás

Brasília, Brasil beBeeRegulatory Tempo inteiro
Job Overview:

As a highly skilled Regulatory Specialist, you will be responsible for maintaining awareness of regulatory legislation, guidance, and practice in assigned countries.

You will coordinate, collect and organize data and information required by regulatory authorities, including the preparation of study documentation such as country application forms and cover letters for sponsor review.

Liaise with internal and external vendors in the generation of regulatory authority submissions and perform a review of final submission documents. Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.

  • Maintain awareness of current regulatory standards related to submissions
  • Act as a local expert in project start-up activities for a particular country or region
  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
  • Collect and track all necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance
Clinical Trials Information System (CTIS) Tasks:

Assist in the upload of submission documentation to CTIS, interacting with and monitoring of all notifications and alerts to ensure all milestones and events for the trial are met within the timelines mandated.

The ideal candidate will have a University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.

Requirements:

Highly motivated and detail-oriented individual who can work effectively in a team environment and maintain confidentiality when dealing with sensitive information.

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