Senior Clinical Compliance Professional

4 semanas atrás

Manaus, Brasil beBeeRegulatory Tempo inteiro
Job Overview \

As a senior regulatory specialist, you will serve as the primary point of contact for investigative sites during site start-up activities and ongoing maintenance.

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Key responsibilities include maintaining awareness of applicable regulations, collecting and organizing data and information required by regulatory authorities, and coordinating submissions to IRB/IEC/Third body/Regulatory Authorities.

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You will also be responsible for reviewing final submission documents, ensuring all assigned start-up and maintenance activities are on track, and preventing and escalating study issues in a timely fashion.

\Clinical Trials Information System (CTIS) Tasks \
  • \
  • Assist in uploading submission documentation to CTIS and interact with notifications and alerts to ensure trial milestones are met within timelines. \
  • Liaise with internal and external vendors in the generation of Regulatory Authority submissions. \
  • Review final submission documents and ensure all assigned start-up and maintenance activities are on track. \
  • Prevent and escalate study issues appropriately and in a timely fashion. \
  • Compile and prepare routine submissions filed to IRB/IEC/Third body/Regulatory Authorities. \
  • Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authorities.
\Qualifications \
  • \
  • University degree (life science preferred) or certification in a related allied health profession from an accredited institution AND 2 years' work experience in clinical research. \
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
\Experience \
  • \
  • Minimum of 3 years of experience in clinical development or start-up/regulatory process. \
  • Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.

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