Remote Regulatory Lead, Clinical Trials & MRI Innovation

School of Medicine; United States; À distance; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Remote work

Résumé du poste

Stanford University School of Medicine seeks a Clinical Trials Regulator Specialist to coordinate planning, regulatory roadmaps, and commercialization plans for MRI lymphatic imaging research. The role emphasizes collaboration with investigators, ARPA-H sponsors, and institutional stakeholders while ensuring IRB and regulatory compliance.

The position is remote with potential transition to translational research coordination for regulatory approvals.

Qualifications

• Experience in clinical trials operations or IRB processes.
• Understanding of regulatory requirements for trials.
• Strong communication and writing abilities are essential.

Responsabilités

• Develop and compile research protocol documents for regulatory submissions.
• Coordinate regulatory submissions and track milestones and metrics.
• Lead liaison with IRB, FDA, and trial sponsors as applicable.
• Assist in organization of sponsor materials and project documentation.
• Support in preparing regulatory guidance and trainings.

Connaissances

Communication skills

Inter-personal skills

Strong writing skills

MS Office

Regulatory affairs knowledge

FDA regulations knowledge

Formation

Bachelor’s degree

Outils

Database applications

MS Office

Description du poste

Stanford University School of Medicine seeks a Clinical Trials Regulator Specialist to coordinate planning, regulatory roadmaps, and commercialization plans for MRI lymphatic imaging research. The role emphasizes collaboration with investigators, ARPA-H sponsors, and institutional stakeholders while ensuring IRB and regulatory compliance.

The position is remote with potential transition to translational research coordination for regulatory approvals.