
Posted 8 hours ago
Ethics Committee Specialist
Tecnológico de MonterreyEspecialista de Comité de Ética
Requirements
Bachelor's degree in Medicine, Biology, Psychology, Nutrition, or QFB, 1-2 years experience in health services or clinical research administration, Knowledge of ISO 9000 and quality systems preferred
Skills
Clinical ResearchComplianceQuality Assurance
About the role
Responsibilities
- Ensure efficient operation, documentary control, and regulatory compliance of Clinical Research Committees in accordance with COFEPRIS and CONBIOÉTICA standards.
- Act as a liaison between researchers, CROs, and Committees to optimize response times and reduce regulatory risks.
- Manage the reception, quality review, and tracking of clinical research protocols prior to committee submission.
- Organize and convene Clinical Research Committee sessions, including preparing agendas and attendance lists.
- Elaborate meeting minutes, evaluation reports, and official response letters for research protocols.
- Maintain and update databases for submitted protocols and billing processes.
- Provide guidance and advisory services to Principal Investigators and residents regarding submission requirements and processes.
- Manage the physical and digital archiving of approved documents, including scanning and securing signatures.
Requirements
- Bachelor's degree in Medicine, Biology, Psychology, Nutrition, or QFB (Químico Farmacéutico Biólogo).
- 1 to 2 years of experience in administrative or clinical activities related to health services, hospitals, or clinical research.
Preferred Qualifications
- Experience with audits and quality management systems (ISO 9000).
About the Company
Tecnológico de Monterrey is a leading institution dedicated to transforming Mexico through education and innovation. We foster a collaborative culture based on inclusion, meritocracy, and respect, providing opportunities for professional growth and meaningful impact.
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Tecnológico de Monterrey · Monterrey
