Senior Compliance Specialist

2 semanas atrás

Belo Horizonte, Brasil beBeeRegulatory Tempo inteiro
Job Overview

The Senior Regulatory Specialist will be the primary contact with investigative sites during site start-up activities and maintenance.

This role is responsible for collecting required documents, ensuring EC/IRB/Third body/Regulatory Authority applications are made within agreed timelines, and that documentation meets applicable regulations and sponsor specifications.

  • Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
  • Coordinate data and information collection for EC/IRB/Third body/Regulatory Authority submissions, including preparation of study documentation.
  • Compile and prepare routine submission files to IRB/IEC/Third body/Regulatory Authorities and liaise with them as applicable.
  • Liaise with internal and external vendors for Regulatory Authority submissions.
  • Review final submission documents as applicable.
  • Ensure assigned start-up and maintenance activities are on track, in accordance with client expectations, and in compliance with applicable laws and guidelines.
  • Prevent and escalate study issues appropriately and in a timely fashion.
In Country Specific Tasks (Global):
  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
  • Collect and track necessary documents, 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 and timely basis, making the organization ready for an audit at any time.
  • Participate in team and project meetings as applicable.
  • Assist in strategy definition for Site Activation, provide accurate projections and timelines to study teams, and review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol.
  • May support negotiation of site contracts with sites, if applicable.
  • Proactively identify and escalate risk to meeting deliverables and notify Submissions Lead of hours identified as Out-of-Scope or overburden.
Clinical Trials Information System (CTIS) Tasks (Centralized Role for EU):
  • Assist in uploading submission documentation to CTIS, interact with, and monitor notifications and alerts to ensure all milestones and events for the trial are met within mandated timelines.
Qualifications:
  • University/College degree (life science preferred), or certification in a related allied health profession from an accredited institution, and 2 years' work experience in clinical research, including ICH guidelines and RA, IRB/IEC regulations.
  • May consider relevant 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; familiarity with investigator start-up documents and contract negotiation process; previous interaction with operational project teams and investigative sites.
Physical Demands/Work Environment:
  • General Office Environment.

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