Laboratory and Clinical Compliance Manager

• Develop and implement compliance programs: This involves establishing and maintaining a robust system for adhering to relevant regulations and guidelines.
• Draft and revise policies and procedures: Creating and updating policies to ensure alignment with current regulations and best practices.
• Monitor and enforce compliance: Regularly checking that all laboratory activities conform to established rules and policies.
• Conduct internal audits and investigations: Performing assessments to identify potential compliance risks and investigate non-compliance issues.
• Provide guidance and training: Educating staff on regulatory requirements and best practices for compliance.
• Maintain accurate records: Documenting all compliance efforts and their results for inspection and review.
• Stay updated on regulations: Keeping abreast of changes in laws, regulations, and industry standards related to laboratory operations.
• Collaborate with other departments: Working with various teams, including laboratory management, quality assurance, and legal counsel, to ensure a comprehensive compliance approach. 

Education:

• Bachelor's degree in a relevant scientific field (e.g., Biology, Medical Technology, Chemistry) is required
• Master's degree is preferred

Experience:

• Several years of experience in a clinical or analytical laboratory setting, with a focus on regulatory compliance at the local State and National level.

Knowledge:

• Strong understanding of federal and state laboratory regulations (e.g., CLIA, PAMA, CMS), and potentially other specific regulations depending on the industry.

Skills:

• Excellent communication, analytical, problem-solving, and organizational skills are crucial. 

Certification:

• Certified Healthcare Compliance (CHC) preferred