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POSITION SUMMARY: 

Under the direction of the Director or designee, the Compliance Coordinator is responsible to develop, direct and implement compliance program components as required by regulatory guidance, regulatory procedures, and changes pertaining to complex validation of the Joint Commission requirements, life safety code, CDC requirements pertaining to Bio level 3 labs and requirements pertaining to the Authority having jurisdiction (AHJ).

ESSENTIAL FUNCTIONS:

• Responsible for ensuring compliance with policies regarding Joint Commission, Life Safety Codes, CDC requirements
• Develop, direct, and implement compliance program components; record keeping, monthly and annual reporting, program evaluation and other compliance issues that meet the applicable government and local regulations and the institution’s policies and practices
• Pro-actively identify protocols that need special review or procedures
• Assist investigators and study teams in preparing and submitting Joint Commission and CDC reports. Interact with AHJ inspectors, SOC inspectors on matters of inquiry and compliance and resolution
• Prepare ongoing summary reports of various data sources, and collaborates with investigators on data presentation, interpretation, and the writing of manuscripts for publication and grant proposals
• Prepare submissions of regulatory documents for regulatory and local bio-safety committees
• Direct regulatory compliance operations, initiate modification of existing policy, and develop new SOPs and training materials
• Oversee paper and electronic submissions to local IRB and other reporting entities as appropriate (federal, industry). Responsible for maintaining, updating, and auditing the regulatory tracking/control systems to ensure compliance with regulatory timelines, license renewal and annual registrations
• Coordinate relationships with affiliated sites to ensure regulatory compliance, oversight, and reporting
• Coordinate and lead site external affiliate audits. Includes preparation, execution, recommendations, and final reporting
• Maintain confidentiality regarding subjects, records, and review of issues
• Perform other duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in a business administration or equivalent experience
• 3-5 years of regulatory experience required.
• 1 year of experience in training and supervision of staff in a regulatory compliance performance
• Must demonstrate good understanding of the Life safety codes, CDC requirements pertaining to BSL3 labs regulatory guidelines, Joint Commission accreditation guidelines
• Demonstrated knowledge with electronic regulatory management platforms, Microsoft Office Suite, and industry related software
• Strong critical thinking skills, proofreading skills, and attention to detail
• Superior organizational skills, with demonstrated ability to juggle and prioritize multiple tasks in a fast-paced environment and consistently meet deadlines
• Excellent interpersonal skills and ability to work collaboratively with other research, academic and clinical personnel at the local and national level
• Excellent written and oral communication skills

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