Senior Regulatory Specialist, Clinical Trials

NALHE; Pleasanton (CA); Sur place; USD 90 000 - 150 000; Plein temps

Résumé du poste

NALHE is seeking a regulatory affairs professional to ensure compliance across FDA regulations, NIH guidelines, and human research protections at the site level. The role involves preparing IRB/FDA documents, maintaining study regulatory files, and supporting inspections and audits.

The successful candidate will develop procedures, educate staff on new guidance, and contribute to the preparation of investigational product applications for approval, coordinating with investigators and staff to

Responsabilités

• Builds effective relationships by providing resources and expertise to teammates.
• Completes tasks autonomously using up-to-date regulatory knowledge to support projects.
• Identifies and addresses process improvements for the team.
• Assists budgeting and funding understanding for projects.
• Conducts clinical research data collection and supports protocol development.
• Ensures documentation and compliance with federal, state, and local regulations.

Description du poste

NALHE is seeking a regulatory affairs professional to ensure compliance across FDA regulations, NIH guidelines, and human research protections at the site level. The role involves preparing IRB/FDA documents, maintaining study regulatory files, and supporting inspections and audits.

The successful candidate will develop procedures, educate staff on new guidance, and contribute to the preparation of investigational product applications for approval, coordinating with investigators and staff to