The Research Compliance Consultant serves as the primary resource in regulatory aspects, providing expertise to ensure research protocols follow 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 follow university, state, and federal regulations.
Responsibilities include assisting with daily oversight of the Regulatory team, monitoring compliance with IRBs, FDA, and federal, state, and industry sponsor regulations, and providing technical support to junior members.
The role involves participating in the development of SOPs and processes, creating and delivering training programs, and staying current on relevant legislation and regulations.
Matching Summary
The Research Compliance Consultant serves as the primary resource in regulatory aspects, providing expertise to ensure research protocols follow university, state, and federal regulations.
Skills & Requirements
Must-have
regulatory expertise
human and animal subjects
IRBs, FDA, federal, state regulations
quality checks of regulatory files
SOP development and processes
Nice-to-have
mentoring and supervising staff
educating physicians and staff
collaboration with operations managers
Key Requirements
Bachelor's degree or equivalent experience
6 years of relevant experience
Knowledge of clinical research regulations
8-12 years of relevant experience preferred
Experience with federal & industry sponsor requirements preferred