Patrick Marshall Email & Phone Number

Responsible for monitoring and auditing clinical, regulatory, business, and other research-related activities and documentation for oncology clinical trials following industry standards and applicable regulations including FDA/OHRP guidance, GCP, and ICH.• Conducted routine risk monitoring visits for all LCI Investigator Initiated Trials.• Conducted QA monitor and audit visits for compliance with study protocol, internal SOPs, and applicable regulations.• Participated in study start-up and follow-up meetings with study sponsors as appropriate including SIVs, monitoring visits, and study closeouts.• Provided education and technical assistance to research staff including orientation and policy change training.• Assisted in the creation and revision of SOPs and internal monitoring plans. • Assisted in successful 2015 FDA audit for industry-sponsored novel drug approval with no 483.

Responsible for reviewing and processing study-related regulatory documentation for research studies at various CHS facilities to ensure strict adherence to organizational and government regulatory requirements. • Tracked and processed all study protocol yearly renewals and closures for bi-monthly IRB meetings; Maintained clinical trial database for tracking active studies, study closures, study sponsors, and study data (enrollment to date, 45 CFR 46 categories, department, and more).• Audited all incoming protocol deviation/violation and serious adverse event submissions and forwarded to appropriate internal reviewer for signature.• Instructed Investigators and Research Coordinators in IRB, FDA, and NIH regulations for research involving human subjects.• Reviewed study applications for compliance with study protocol and appropriate regulations; investigated incomplete, inaccurate, or missing documents as required for audit by regulatory agencies.

Responsible for conducting technical research procedures and providing clinical and preclinical study support to primary investigators, surgical fellows, and surgical residents.• Assisted in preparation of study document submission to institutional review board and institutional animal care and use committee, maintenance of regulatory binders, subject enrollment, study specimen collection, and preparation for internal/external audits.• Researched prospective and retrospective study data in EMR and prepared for analysis to support multiple grant-funded clinical research projects and publications.• Responsible for supervising all in vivo and in vitro procedures including: cell culture, bacterial culture, tissue banking, and cellular assays.

Responsible for successful planning and execution of in-house pre-clinical device research studies to develop novel technologies for poultry industry worldwide. • Contributed to diagnostic DNA assay development research with cross-functional support from engineering and manufacturing department for feasibility and safety testing.• Utilized design research methodology to identify new product opportunities and areas for growth. • Responsible for in-vivo lab procedures, SOP creation and revision, WI creation and revision, safety monitoring, data collection and analysis, teammate education, and internal/external audit preparedness.

Led coordination of in-house ovarian cancer pre-clinical trial with strict adherence to National Health Institute grant requirements. Assisted in development of novel technologies in field of genetic manipulation in two species of frog.• Created dosing formulation of investigational new drug for prevention of ovarian cancer in humans using poultry as model. Successfully identified and documented toxicity effect in high dose treatment group through histology and pathology.• Responsible for cancer cell culture, tissue banking, Western blot, gel electrophoresis, DNA mapping, SOP creation and revision, safety monitoring, data collection and analysis, monthly NIH progress reports, CRFs, and final reports/publications.

Support of all in-house pre-clinical trials with adherence to study protocols to meet PI needs for 11 project teams. • Served as liaison between clinical support team and vaccine development group including involvement in discovery research projects to develop novel anti-coccidial and anti-viral vaccines for poultry industry worldwide.• Conceived and executed development of enrichment program to reduce cannibalism in trial birds from 30% per study to 0-5% per study.• Led team in the successful completion of in-house Select Agent studies with vaccine development group including data record management, clinical signs monitoring, and review of data records prior to submission to USDA.