The Research Compliance Consultant serves as the primary resource in regulatory aspects by providing regulatory expertise to ensure research protocols are following university, state and federal regulations
Job Summary
The Research Compliance Consultant serves as the primary resource in regulatory aspects by providing regulatory expertise to ensure research protocols are following university, state and federal regulations.
Assists CCRM Regulatory Leadership with the daily oversight of the Regulatory team and monitoring of the regulatory research compliance functions across all research sections/disease groups.
Stays current on legislation, rules, regulations, procedures, and development; educates physicians and staff regarding changes related to clinical research protocols.
Matching Summary
The Research Compliance Consultant serves as the primary resource in regulatory aspects by providing regulatory expertise to ensure research protocols are following university, state and federal regulations.
Skills & Requirements
Must-have
regulatory expertise for research protocols
monitoring regulatory research compliance
subject matter expert for regulatory compliance
quality checks of regulatory files
development of SOPs and processes
onboarding and educational training programs
Nice-to-have
mentoring and supervising staff
technical support to junior members
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