
Clinical Research Compliance Professional
4 semanas atrás
Job Title: Regulatory Compliance Specialist
This role involves coordinating with investigators, regulatory authorities, and other stakeholders to ensure compliance with relevant regulations and guidelines. The ideal candidate will possess a strong understanding of ICH, RA, IRB/IEC regulations and have experience in clinical research.
About the Role:
- Coordinate site start-up activities and maintenance, ensuring timely submission of required documents to regulatory authorities.
- Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
- Liaise with internal and external vendors regarding Regulatory Authority submissions.
Key Responsibilities:
- Review and prepare routine submissions filed to IRB/IEC/Third body/Regulatory Authorities.
- Ensure assigned start-up and maintenance activities are on track, in accordance with client expectations and applicable laws and guidelines.
Qualifications and Requirements:
- University/College degree or certification in a related allied health profession from an accredited institution.
- 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.
Desirable Qualifications:
- 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.
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