Clinical Research Regulatory Specialist

Há 6 dias

Jacupiranga, Brasil beBeeRegulatory Tempo inteiro R$200.000 - R$350.000
Job Opportunity

The selected candidate will be responsible for maintaining awareness of regulatory legislation and guidance in assigned countries. This includes coordinating the collection and organization of data and information required by regulatory authorities, as well as preparing study documentation such as country application forms and cover letters. The role also involves compiling and preparing routine submissions filed to IRB/IEC/Third Body Authorities and liaising with them regarding submission/approval.

Key Responsibilities:
  • Maintain awareness of regulatory legislation and guidance in assigned countries.
  • Coordinate the collection and organization of data and information required by regulatory authorities.
  • Prepare study documentation such as country application forms and cover letters.
  • Compile and prepare routine submissions filed to IRB/IEC/Third Body Authorities.
  • Liaise with regulatory authorities regarding submission/approval.

Country Specific Tasks:

  • Serve as primary contact for investigative sites and ensure documents are collected in a timely manner.
  • Collect and track all necessary documents required and perform quality review, formatting, and compilation of final documents for effective and compliant site activation and maintenance.
  • Ensure high-quality documents are filed and systems are updated on an ongoing basis, making the company ready for an audit at any time.

Clinical Trials Information System (CTIS) Tasks:

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

Qualifications and Experience:

  • University degree or certification in a related allied health profession from an accredited institution.
  • Minimum 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.
  • Relevant equivalent experience may be considered in lieu of educational requirements.

Desirable Skills:

  • Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.
  • Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budget negotiation process.

What We Offer:

A dynamic and challenging environment that allows you to grow and develop your skills and expertise in the field of clinical research.

How to Apply:

Submit your application through our website, including your resume, cover letter, and any supporting documents as requested.

Keyword: Regulatory Specialist

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