Research Compliance Specialist, Full Time Day Shift
About The Position
The Research Compliance Specialist develops, oversees, and monitors the organization’s research compliance functions. These functions include animal care and use, protection of human subjects, research involving biohazardous agents and DNA, export controls, clinical-trial billing rules, grants management issues, and controlled substances. The role assists with development and implementation of the annual work plan and identifies performance indicators to measure the effectiveness of the research compliance program. The position runs program(s) with moderate budget/impact. The specialist conducts research-related risk assessments, internal investigations, and operational audits; identifies potential compliance vulnerabilities; and recommends improvements to internal controls. The role also develops and delivers training, monitors regulatory developments, assists with interpreting applicable laws and regulations, and oversees investigation and resolution of non-compliance, including corrective action. Decisions are guided by precedents, policies, and objectives, and the work may involve complex, varied, or non-recurring problems.
Requirements
- Associate’s/Technical Degree or equivalent combination of education and related experience is required.
Nice To Haves
- Bachelor’s Degree preferred.
- Five years of technical experience preferred.
Responsibilities
- Develop, oversee, and monitor organizational research compliance functions, including animal care and use, human-subject protection, biohazardous agents and DNA, export controls, clinical-trial billing, grants management, and controlled substances.
- Assist with development and implementation of the annual work plan and identify performance indicators to measure the research compliance program’s effectiveness.
- Conduct risk assessments, internal investigations, and operational audits of research-related issues to monitor compliance with applicable laws, regulations, policies, and procedures.
- Identify potential research compliance vulnerabilities and recommend improvements to internal controls.
- Develop and deliver research compliance training and education curricula, and create related training tools and materials.
- Monitor regulatory developments and changes, and assist with interpreting emerging federal, state, and local laws and regulations related to research compliance review and oversight.
- Evaluate instances of non-compliance, conduct further investigation, and oversee follow-up and resolution, including corrective action.
- Make decisions and recommendations on issues affecting a department or functional area, and use appropriate diagnostic and performance-improvement techniques to resolve complex problems.
- Perform other job-related duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
