Joseph Hatch Email and Phone Number

• Perform all work in compliance with company policy and within the guidelines of BFDX’s Quality System• Coordinate and manage all aspects of BioFire’s clinical studies, acting as BioFire’s liaison • Conduct routine monitoring visits on behalf of the clinical trial; sponsor• Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification)• Write the Statements of Work (SOWs), cost proposals, and other documents… Show more • Perform all work in compliance with company policy and within the guidelines of BFDX’s Quality System• Coordinate and manage all aspects of BioFire’s clinical studies, acting as BioFire’s liaison • Conduct routine monitoring visits on behalf of the clinical trial; sponsor• Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification)• Write the Statements of Work (SOWs), cost proposals, and other documents required for studies • Manage the timeline, budget, and investigational device inventory for the clinical studies• Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system)• Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools)• Verify that the research site personnel, including the investigators are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements• Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC• Provide logistical, technical, and regulatory support to BFDX’s lab, study physicians, and clinical volunteers to ensure that all participants have the necessary equipment, training, and materials to fulfill their role in the studies• Develop and maintain online study websites, documents, and surveys• Write all reports, including appropriate sections of the regulatory submissions resulting from the clinical studies• Perform related lab duties and experiments• Prepare technical reports, summaries, protocols, and quantitative analyses relating to real-time PCR• Contribute to project process within my scientific discipline Show less

• Perform all work in compliance with company policy and within the guidelines of BFDX’s Quality System• Coordinate and manage all aspects of BioFire’s clinical studies, acting as BioFire’s liaison • Conduct routine monitoring visits on behalf of the clinical trial; sponsor• Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification)• Write the Statements of Work (SOWs), cost proposals, and other documents… Show more • Perform all work in compliance with company policy and within the guidelines of BFDX’s Quality System• Coordinate and manage all aspects of BioFire’s clinical studies, acting as BioFire’s liaison • Conduct routine monitoring visits on behalf of the clinical trial; sponsor• Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification)• Write the Statements of Work (SOWs), cost proposals, and other documents required for studies • Manage the timeline, budget, and investigational device inventory for the clinical studies• Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system)• Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools)• Verify that the research site personnel, including the investigators are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements• Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC• Provide logistical, technical, and regulatory support to BFDX’s lab, study physicians, and clinical volunteers to ensure that all participants have the necessary equipment, training, and materials to fulfill their role in the studies• Develop and maintain online study websites, documents, and surveys• Write all reports, including appropriate sections of the regulatory submissions resulting from the clinical studies• Perform related lab duties and experiments• Prepare technical reports, summaries, protocols, and quantitative analyses relating to real-time PCR• Contribute to project process within my scientific discipline Show less

Followed cGMP, cGLP, facility SOPs, and FDA guidelines to validate new RT-PCR rapid detection systems and assays for 510(k) clearanceCertified to work in and manipulate organisms in a BSL-2 environment.Order primers and probes for use in newly developed RT-PCR assays.PCR assay development and optimization.DNA and RNA nucleic acid extraction and purification of clinical specimens.