Frank McAneny

About Frank McAneny

I am a dedicated and dynamic professional with a proven track record of leadership and success in research compliance, regulatory affairs, and project management within the healthcare sector. My career has been defined by my ability to navigate complex regulatory landscapes, build and oversee compliance programs, and ensure the ethical conduct of research involving human subjects, animals, and hazardous substances.As the Director of Research Compliance at Sitero, LLC, I oversee the effective conduct of multiple regulatory committees, including DSMBs, IRBs, IACUCs, and IBCs. My role involves developing and maintaining policies and procedures to ensure compliance with relevant regulations, providing guidance and education to researchers and staff, and serving as the primary point of contact for regulatory agencies. I excel in identifying compliance issues, developing strategic solutions, and fostering a culture of compliance and excellence.Throughout my career, I have managed diverse teams, implemented educational initiatives, and developed policies to address emerging compliance issues. My strong communication and interpersonal skills, coupled with a comprehensive understanding of healthcare compliance, have enabled me to make significant contributions to organizational success. I hold advanced degrees in Health Care Administration and Business Administration, along with industry-recognized certifications.I am passionate about promoting ethical and compliant research practices and am committed to continuous improvement and professional development. I look forward to connecting with like-minded professionals and exploring new opportunities to contribute to the field of healthcare compliance.

Experience

1. Director of Research Compliance (Remote)

   Sitero

   Oct 2022 — Present

   Oversees the effective conduct of the Institutional Review Board, Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC), ensuring that all committees function effectively and efficiently.• Serving as a permanent voting member and regulatory expert on the IRB and serving as an ex-officio advisor to the IACUC and IBC.• Develop, implement, and maintain policies and procedures to ensure compliance with all relevant regulations and guidelines related to research involving human subjects, animals, hazardous substances, and biosafety.• Direct, support, and develop the IRB, IBC, and Biosafety team as assigned and liaise with other areas to resolve research compliance-related issues.• Provide guidance, information, and education to researchers, staff, students, and administrators regarding interpreting and implementing the regulatory requirements related to research misconduct. • Serve as the primary point of contact for regulatory agencies and oversee all communications and interactions with these agencies in consultation with the Institutional Official, Sitero Administration, and Legal Counsel.• Identifies compliance issues and establishes procedures that foster research performance compliant with federal regulations, state laws, and internal policies.• Ensuring that semi-annual facility inspections, programmatic animal care, and program reviews are conducted and documented per federal regulations.• Developing and presenting educational and training sessions about the ethical conduct of human, biosafety, and animal subject research and the IRB/IACUC/IBC process.• Creating and maintaining submission forms for the IRB, IACUC, and IBC via the Sitero Mentor research compliance platform.• Serve as the Human Protections Administrator and submit annual FWA submissions with HHS.• Submit and maintain IBC registrations with NIH on behalf of customers

Education

• Georgia State University

  Bachelor of Arts - BA

  1999 — 2003

• Utica College

  Master of Science - MS

  2017 — 2018

• Gardner-Webb University

  Master of Business Administration - MBA

  2010 — 2014