Site Regulatory Specialist - Oncology Research

McKesson Corporation; Denver (CO); Presencial; USD 37 000 - 47 000; Tempo integral

Resumo da oferta

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Site Regulatory Specialist to manage and track regulatory documents and protocol training to maintain site compliance with FDA and GCP requirements. You will collaborate with the regulatory affairs team, site leadership, and principal investigators to prepare for audits and meet deadlines.

This role requires an Associate's degree or higher, knowledge of clinical research terminology, and experience in a customer-focused

Qualificações

• Associate's degree, preferably Bachelor's.
• Knowledge of medical and clinical research terminology.
• At least one year of experience in a customer-focused position.
• At least three years of clinical research experience preferred.
• At least three years of regulatory experience preferred.
• SOCRA certification preferred.
• ACRP certification preferred.

Responsabilidades

• Provide site-level regulatory support related to start-up and ongoing regulatory maintenance.
• Establish and maintain a document management system for regulatory files.
• Maintain updated physician credentials and other critical documentation.
• Meet with monitors and auditors to review regulatory binder.
• Track documents pending site regulatory signatures.
• Route and track completion of protocol training.
• Maintain FDA and GCP regulatory documentation for site, studies, sponsors and networks.
• Ensure regulatory documents comply with local SOPs.

Conhecimentos

Clinical research terminology

Customer service

Formação académica

Associate's degree

Ferramentas

SOCRA certification

ACRP certification

Descrição da oferta de emprego

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Site Regulatory Specialist to manage and track regulatory documents and protocol training to maintain site compliance with FDA and GCP requirements. You will collaborate with the regulatory affairs team, site leadership, and principal investigators to prepare for audits and meet deadlines.

This role requires an Associate's degree or higher, knowledge of clinical research terminology, and experience in a customer-focused