Scientific member for Ochsner Health System Institutional Review Board. I am responsible for review of and recommendations to informed consent documents to ensure clear, accurate, complete and regulatory compliant informed consent documents are approved.

Certified IRB Professional (CIP) Oversight of daily IRB operations including 2 team members, 3 monthly panels, new study, continuing review, and amended submissions. The IRB reviews over 250 studies per year with average turnaround times less than 30 days for full Board review and less than 1 week for expedited and exempt submissions. Trained as an expedited reviewer for minimal risk studies.  Developed, implemented, and maintains a QA reporting system for the Ochsner HRPP. This is a RedCap system designed for the capture of QA reviews, findings, and follow-up that allows for reporting of metrics. Involved in quality assurance reviews with the HRPP QA team. Lead the first systematic QA review of the Research Pharmacy in 2016, which lead to improvement in drug accountability processes and fewer IP deviations.  Acts as the project lead for the eIRB system. In 2017 undertook the first major upgrade to this system in over a decade including business needs analysis, QA & UAT testing, CTMS interface, and training of end users. Continues to maintain the eIRB, implement patches and conduct trainings as necessary.  Co-chair of the eRegulatory adoption committee with responsibilities for all discovery, vendor communication, stakeholder buy-in, and working with other departments such as IT to ensure integration with existing systems.  Educates CRCs on research ethics including informed consent, regulatory compliance, adverse events, protocol deviation reporting, and CAPA creation.  Development and maintenance of HRPP SOPs, creation of guidance documents for Research systems and interpretation of policies and regulations.  Committee Member for Ochsner Research Day an annual event that highlights institutional research efforts. Responsible for securing educational credits.  Committee Member for the Ochsner Evidenced Based Practice Nursing Conference an annual conference. In charge of all volunteer coordination and day-of activities.

Atelier Vie creates and distills a variety of really cool liquors. We are the first producers of legal absinthe in Louisiana since the ban on absinthe was lifted in 2007. Toulouse Red and Toulouse Green are odes to the new and the old of absinthe with lusty, rich anise flavors.We produce a gold medal winning gin, Euphrosine Gin #9 with our secret botanical ingredient: Bay Leaf. Awarded Gold at American Craft Spirits Association in 2014, Gold and Best in Category at American Distilling Institute in 2014 Euphrosine Gin #9 is gin created for those who love gin.Riz an American Whiskey pronounced New Orleans style. 100% Louisiana rice on the mash bill, hand-made with love and burn wounds.ateliervie.com

 Conducted real-time quality control reviews for high enrolling, fast paced trials (more than 100 subjects/week) with a process for immediate evaluation of informed consents and source documentation to prevent and alleviate protocol deviations.  Worked with the PI and Sponsors to identify any major protocol violations that required creation of a CAPA. Led CAPA implementation with training and didactic workshops for study personnel including Sub-Investigators and CRCs.  Conducted regular study level quality assurance reviews for all drug and device trials. Special emphasis was placed on any trial selected for sponsor audits that resulted in multiple successful audits from large pharma companies.  Developed training processes for newly onboarded staff including a checklist of basic skills, and hands-on practicums.

During my tenure with Benchmark I was promoted twice, first from Assistant CRC to full CRC and again when I sat for and passed the ACRP CRC certification examination.  Provided coordination for Phase I-IV drug and device trials. From study start up handled all aspects of regulatory and IRB submissions, recruitment and retention of study subjects, maintenance of regulatory binders, EDC entry and query resolution through study close out.  Conducted quality control of in-house source document creation known at the company as a document liaison. The document liaison was responsible for reviewing all source documents created by CRCs. This required thorough review of the protocol, operations manuals, and other materials to create a complete source document that facilitated protocol compliance and reduced protocol deviations.  Led quality assurance reviews for all studies that were selected for sponsor audits and FDA audit.  Performed training for all new CRCs on the Clinical Conduct CTMS system.

Design and implementation of molecular and biological experiments including mouse models, tissue culture, bacteriological and chemical assays. Plasmid replication, western blots and primary cell line creation among my primary expertise.

Working in conjunction with physicians and registered nurses to provide emergent and urgent care to patients presenting to the emergency department including peripheral IV insertion and maintenance, phlebotomy, temporary splinting, triage and facilitation of patient transfer to higher level care facilities if necessary.