Optimizing clinical trial site operations through consulting support with new/naïve/experienced sites from study start up to close out. Supporting ethical clinical trial conduct through adherence of regulations & ICH/GCP.• Consulting with new/naïve/experienced sites to streamline start up processes.• Guidance with study budget & contract review.• Coach sites to recruit, hire and onboard new team members with robust training.• Support and lead QA/QC facility operational design and development• Confer with sites for ethic committee/IRB reporting & maintenance.• Advise sites with CAPA development & implementation for audit rescue.• Develop diversity practices to increase under-represented population enrollment in clinical trials.

Phases: II, III, IV Drugs, Devices, IIT, Single Patent INDTherapeutic Areas: Infectious Diseases (HIV/AIDS, STD/STIs, COVID)Oversee day-to-day operations of the Clinical Research Department for a Federally Qualified Healthcare Center (FQHC) committed to improving diversity & affirming health care to Chicago’s under-represented populations in clinical trials.

Create innovative course lectures, examinations and assignments.

Responsible for total study management including: patient visits, collection of data, source documentation, regulatory. Performed duties: laboratory specimen processing/shipping, EKG testing, phlebotomy. Therapeutic Area: Multiple Sclerosis/Drugs and Devices Phases II-IV

Responsible for total study management. Provided management support with training. Performed duties: pulmonary function testing(PFT), skin prick testing/evaluation, laboratory specimen processing/shipping, EKG testing, phlebotomy. Therapeutic Areas: Dermatology, Respiratory, Infectious & Immunology/Drugs and Devices Phases II-IV