Joshua G. Email & Phone Number

Logan, OH, US

Athens, Ohio, US

I serve as Ohio University’s inaugural Chief Privacy Officer. Additionally, I actively represent Privacy in the following groups:· Alternate scientific member of the Biomedical Institutional Review Board (IRB)· Information Security Governance Committee· Institutional Accreditation Committee· Administrative Senate· Research Data Management Work Group

Lancaster, OH, US

·Investigated and responded to all alerts received through our privacy monitoring application, FairWarning· Responsible for timely notifications to patients and HHS· Responded to privacy complaints received by the Department of Health and Human Services’Office of Civil Rights· Presented HIPAA to new employees during orientation on a biweekly basis·.

Columbus, Ohio, US

• Served as the Regulatory Compliance Officer for all new, industry and investigator initiated, heme cell therapy and human gene transfer (HGT) protocols.
• Worked with the FDA at all stages of a study from applying for an IND during the initial submission to annual follow-up, study closure through NDA.
• Acted as a preceptor for the RCO who successfully took over my multiple myeloma trials.
• Served as a resource to other regulatory staff regarding our E-regulatory system that I assisted in validating prior to it being implemented in February 2019.
• Served as a resource to other regulatory staff regarding cell therapy/HGT protocols.
• Charged with ensuring trials were initiated efficiently and completed on time, according to budget and in compliance with SOPs, FDA regulations, and ICH/GCP

Columbus, Ohio, US

• Responsible for data of up to 5 PI initiated and Industry-sponsored trials ranging from Phases I-III.
• Utilize data to assess patient eligibility as well as toxicity; following protocol design to assure all protocol data elements are collected in accordance with protocol guidelines.
• Collaborate with Principal Investigators, Sponsor Agencies, Research Specialists, and Coordinators, to meet and exceed each patient's and study's needs.
• Assist the Clinical Research Coordinator with patient eligibility screenings and follow-ups.
• Promoted to Regulatory Compliance Officer within the same department, Clinical Trials Office.

Columbus, OH, US

• Signed off by the Pathologist/Director of Surgical Pathology within 4 months, before the 6 month expected training timeline, to gross surgical biopsies.
• Trained to perform gross descriptions and dissections of human tissue ranging from GI biopsies up to more complex Mohs, LEEP, and neuro specimens.
• Played a key role in making sure the lab was compliant with the transition to GHS. Myself and one other tech were responsible for reviewing the new labeling standards and implementing them throughout the lab.
• Trained by Ohio State's Environmental Health and Safety team on the Resource Conservation and Recovery Act (RCRA) to understand the regulations for our lab that is a small quantity generator of hazardous waste.
• Maintained our 4 tissue processors, which include the Leica ASP300S and Sakura VIP
• Acclimated to volume increases during 2015, which increased over 30% from the previous year.

Bachelor Of Science (Bs), Biology/Biological Sciences, General

Pre-Medicine/Pre-Medical Studies