The Research Compliance Consultant serves as the primary resource in regulatory aspects, providing expertise to ensure research protocols adhere to university, state, and federal regulations
Job Summary
The Research Compliance Consultant serves as the primary resource in regulatory aspects, providing expertise to ensure research protocols adhere to university, state, and federal regulations.
Responsibilities include assisting with daily oversight of the Regulatory team, monitoring compliance with IRBs, FDA, and sponsor regulations, and answering questions for junior team members.
The role involves participating in the development of SOPs, creating and delivering training programs, and providing regulatory guidance to research teams.
Matching Summary
The Research Compliance Consultant serves as the primary resource in regulatory aspects, providing expertise to ensure research protocols adhere to university, state, and federal regulations.
Skills & Requirements
Must-have
regulatory aspects of research protocols
university, state, and federal regulations
Institutional Review Boards (IRBs)
FDA regulations
industry sponsor regulations
develop SOPs and processes
onboarding and educational training programs
Nice-to-have
mentoring and supervising staff
quality checks of regulatory files
educating physicians and staff on changes
Key Requirements
Bachelor's degree or equivalent experience
6 years of relevant experience
Knowledge of clinical research regulations and compliance
8-12 years of relevant experience preferred
Experience with federal & industry research sponsor requirements preferred