Regulatory Affairs - Biosafety Consultant

POSITION TITLE: Biosafety Consultant

DEPARTMENT: Office of Research Compliance and Regulatory Affairs (ORCRA)


COLLABORATIVE RELATIONSHIPS: Chair, Institutional Biosafety Committee; Chemical Hygiene Officer; Infection Control Department; Employee Health Department; Occupational Safety and Environmental Health; Lab Safety Committee; Environment of Care Committee; Protective Services; Laboratory Administration; Plant Operations Personnel, Veterinary Services.

TITLES SUPERVISED:Research Compliance Specialist - Biosafety


PURPOSE OF POSITION: To serve as an expert resource in the development, implementation, management and improvement of institutional biosafety programs, files, documents related to biosafety in a Medical Center dedicated to the care of infants, children and adolescents. To analyze data, incident reports and audits in order to provide input to the development of corrective and preventative practices and procedures related to biosafety and health issues.

·Technical Consultation
Serve as an expert resource by developing, implementing, and directing a comprehensive biological safety program throughout all research lab and clinical areas that meet NIH, CDC, OSHA, and granting agency requirements. Serve as a member of the Institutional Biosafety Committee (IBC). Assist IBC Chair by interacting with investigators whose work is under review by committee, reviewing all research protocols to ensure adequate biosafety measures are included, providing guidance to IBC on containment issues, and implementing IBC-approved policies and plans. Maintain in-depth knowledge of biosafety principles and best practices and serve as a resource on related federal and state regulations. Review professional publications, studies and articles to understand best practices and current trends related to biosafety programs and improvements. Transmit this knowledge to OSEH and ORCRA staff. Assist investigators, provide guidance and expertise to staff with matters related to biosafety, including biological agent shipping requirements (including select agent transfer), bio-containment practices, risk assessment, regulations/guidelines interpretation for biological agents and rDNA. Act as point person for infectious waste inspections of research & clinical laboratories by regulatory agencies.
·Evaluating Institutional Biosafety Performance
Work in conjunction with the Directors of OSEH and ORCRA and lab management to develop, conduct and audit lab biosafety and health performance & training. Develop computer generated audit results data, including trends and historical data for the IBC, EOC Committee, and other leadership groups as necessary. Prepare & distribute reports that summarize trends and biosafety concerns. Assist the IBC response to laboratory audits and follow-up to develop corrective and preventative practices and procedures related to biosafety issues. Conduct periodic comprehensive biosafety program evaluations.
Provide education, including advanced BBP training, to research personnel through structured presentations and unstructured interactions. Assures that appropriate CCHMC staff receives adequate training on shipping of hazardous goods (infectious agents, biological specimens, and dry ice). Provide training on emergency response plans for research and clinical laboratories handling accidental spills and personnel contamination with biohazardous materials. Collaborate in the development of targeted training to meet organizational needs.
·Incident Investigation
Assist the IBC, Employee Health, and OSEH response to employee incident investigations and follow-up to develop corrective and preventative practices and procedures related to biosafety issues.
·Process Improvement
Monitor the effectiveness of institutional biosafety practices and develop evidence based improvement priorities for the CCHMC biosafety program. Seek to adopt interdisciplinary process improvement practices for biosafety program. Develop & distribute computer generated data, including trends and historical data that summarize trends and safety concerns for the IBC and other internal groups as necessary. Collaborate, advise, educate and serve as a resource to managers and supervisors regarding biosafety matters. Recommend strategies for improving processes and compliance.

Skills & Competencies
·Technical Expertise:
Advanced knowledge of worker and chemical safety practices and working knowledge of applicable OSHA/EPA regulations as well as consensus guidelines (ANSI, NIOSH, ASHRAE, etc). Advanced ability to interpret such regulations and guidelines, develop/revise CCHMC policies accordingly, and build relationships within CCHMC to implement any necessary changes.
Advanced skills in operational flexibility. Proficient skills in creativity and innovation. Resource Management: Advanced skills in problem solving. Computer literate and working knowledge of software applications (word processing, spreadsheet, and database).
·Personal Effectiveness:
Advanced skills in leveraging diversity, team building, and partnering with clients. Advanced skills in being customer focused, resilient, politically savvy, and decisive. Advanced ability to be accountable. Demonstrated integrity and honesty. Possess physical stamina sufficient to lift 40 lbs., and to walk extensively.
·Education & Development:
Demonstrated continued learning.
Advanced oral, written, interpersonal, negotiating, influencing, and platform communication skills sufficient to influence and market ideas.

·Bachelor's degree in Microbiology, Chemical Engineering, Chemistry OR Industrial Hygiene experience
·10 years progressively responsible experience
·Responsible and complex professional experience in a Health and Safety function

·Master's Degree
·Experience in a laboratory setting