Spokane, Washington
Regulatory Compliance Analyst Job Opening in Spokane, Washington - Job Purpose
The Regulatory Compliance Analyst will operate guided by the Regulatory Compliance Officer conducting internal compliance reviews to assess compliance with federal and state laws, regulations, guidance, and international standards, as well as PCR Policies & Procedures. Duties may focus on one or both elements of either GCP/responsible study conduct; or research billing compliance. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
Duties and Responsibilities
Working knowledge of federal regulations and international standards related to the conduct of research, human subjects research, clinical research billing, and grants. These may include, but are not limited to the following: Department of Health and Human Services, Office of Human Research Protections, Office of Research Integrity, Food & Drug Administration, Office of the Inspector General, Office of Civil Rights, Centers for Medicare and Medicaid, International Conference of Harmonization GCP standards.
Ability to recognize noncompliance with federal regulations and consult with Compliance Manager for clarification and assistance in the interpretation of regulations when appropriate, escalating suspected or potential continuing and/or serious noncompliance.
Ability to locate appropriate sources of research related federal regulations and guidance documents for independent research and review.
Ability to independently conduct detailed and thorough analysis and compliance reviews of identified research projects, and/or research billing practices and processes.
Excellent verbal and written communication skills, including proficient writing skills as demonstrated by writing thorough and concise reports of completed compliance reviews.
Analytical and critical thinking skills are necessary to anticipate and identify potential problems and for problem solving.
Ability to work well independently, attention to detail, organized, self-starter. Good time management and organizational skills.
Ability to effectively communicate and collaborate with a variety of professionals and other departments including operations, clinical, financial, and administrative.
Proficient in Microsoft Office Suite, particularly Outlook, Word, and Excel.
Ability to maintain strict confidentiality of employees, other research team members, patients, research subjects, and business information.
Ability to recognize a high standard of ethics in research operations.
Knowledge of electronic research management systems for IRB (Institutional Review Board) management, clinical research management, and/or grants management, especially IRBNet and Clinical Conductor. (preferred)
Qualifications
Bachelor?s degree in healthcare, administration, or research related field.
Three (3) years or more of experience in research (clinical trials).
Experience in areas of research regulatory compliance, research GCP compliance, research billing compliance, clinical trials management (such as research department manager or experience working in a system-wide clinical trials office), grants administration. (preferred)
Job Type: Full-time
Salary: $50,000.00 /year
Required education:
Bachelor's
Required experience:
Clinical Trial Research: 3 years
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