Regulatory Lead for Alzheimer’s Trial Platform

Mass General Brigham; Somerville (MA); Hybride; USD 49 000 - 82 000; Plein temps

Résumé du poste

Mass General Brigham's McCance Center for Brain Health is seeking an experienced Regulatory Affairs Coordinator to lead regulatory risk management for a nationwide Alzheimer's platform trial.

The role involves preparing regulatory documents, coordinating IRB submissions, ensuring compliance with FDA regulations, and mentoring staff. Hybrid work location at 399 Revolution Drive, Boston area, with 40 hours weekly.

Qualifications

• Bachelor’s degree in healthcare management or related field required; Master’s degree related field preferred
• 3-5 years experience in Clinical Research Regulatory Affairs
• Strong understanding of regulatory requirements for clinical research, including FDA regulations
• Excellent organizational and project management skills to manage multiple regulatory submissions
• Effective communication and interpersonal skills for collaboration with diverse stakeholders and regulators

Responsabilités

• Monitor and interpret current regulatory requirements, guidelines, and standards applicable to clinical research studies
• Ensure that all research activities, documents, and processes adhere to relevant regulations
• Oversee the preparation, submission, and tracking of study-related documents to the IRB for ethics review and approval
• Prepare and maintain essential regulatory documents (investigator brochures, informed consent forms, study protocols)
• Collaborate with research teams to ensure timely initiation of clinical studies, including regulatory document collection and site activation processes
• Support internal and external audits related to regulatory compliance and documentation
• Oversee adverse event reporting and safety monitoring in accordance with regulatory guidelines and study protocols

Connaissances

Regulatory requirements

FDA regulations

EDC/EMR/CTMS

Communication skills

Project management

Problem solving

Formation

Bachelor's degree in healthcare management or related field

Master's degree related field preferred

Description du poste

Mass General Brigham's McCance Center for Brain Health is seeking an experienced Regulatory Affairs Coordinator to lead regulatory risk management for a nationwide Alzheimer's platform trial.

The role involves preparing regulatory documents, coordinating IRB submissions, ensuring compliance with FDA regulations, and mentoring staff. Hybrid work location at 399 Revolution Drive, Boston area, with 40 hours weekly.