Christopher Johnston

A father, I work (career-critical-research-work) offering clients invaluable background having participated in clinical allied-health since high school. I graduated from Master of Science, Clinical Research Management Regulatory Science (2012) now Ph.D. in Public Health: Epidemiology candidate. Earlier degrees were: Associate of Science (1998), and Bachelor of Science (2007). I acquired invaluable clinical expertise by work in multiple venues and clinical health settings, developing a broad base of support to mindfully guide everyday clinical oversight. I selflessly volunteered in community search and rescue. I worked as CRA-Monitor with Neuro-pharmaceutical company. I remain active in (ACRP) chapters and global conferences, having attended ACRP’s (2015 & 2016) global conferences. If client needs a research professional who has flexible organizational-research skills, my allied-health background immediately resources to fill such a need. I minored in Organizational Leadership during Bachelor of Science Nursing (BSN) degree. During CRA employment, I helped research manager start a challenging study that had a problematic protocol. I helped the company save time and expense via avoiding amendment of that protocol and instead communicating closely with sites via newsletters and trans functional collaboration. His clinical-allied-health background is extensive, robust, and diverse! A lifelong learner, I am a US-global BioPharma research professional who does not see the Clinical Research Professional role as a punch-the-clock, 9-to-5 job; I endeavor to become your “Right Hand”—helping manage day-to-day operations delegated to Clinical Research Professionals. I volunteer for special projects, and ensures research programs, and sites remain positioned for growth and collection of the critically needed reproducible, scientifically valid deliverables and data sets. CRA-Monitor and medical chart audit during 24hour review has prepared me for meticulous source document verification and familiarity with safety tracking via (MedWatch, CIOMS, etc.), thorough a functional understanding of the metrics surrounding homeostasis and potential assessment of causality. Further, past work prepared for mindful project management and critical, complete, accurate data entry into: Medrio, Oracle Clinical Data and Medidata Rave Electronic Data Capture {EDC}) for source data. I am also skilled for MedDRA, WHO dictionaries to codify adverse events of drug products, medical terminologies, and to check-assess interim trends, relationships, and other contributory reasonably-linked event causality; ensuring meticulous quality in regulatory submission. I have drafted trip reports, generated final trip report and follow up letters. I tracked queries, and query-reconciliation after capture of missing, questionable data, case information, and-or possible clinical metrics affecting outcomes, and learning of causality metrics as necessitated. During my Master's of Science, Clinical Research Management, Regulatory Science program, I acquired Regulatory Science-Affairs knowledge for CFR Title 21 requirements for IND, NDA, BLA, PMA, IDE, UDI, 510(k) along with FDA regulations and FDA Quality system regulations. Chris also acquired knowledge of ICH E6 GCP guidelines, good manufacturing practices, good laboratory practice, good clinical practices and good pharmacovigilance practices.

Scuba diving, Snowboard, World travel, education, foreign languages, younger Vietnamese, Ukrainian, Polish, Russian, Thai, or Filipina bride.