Professor of Academia in the Regulatory Affairs Program and Clinical Research Program in the Allied Heath & Life Sciences Department.Curriculum advisor and guidance support within the department.Experience in creating student awareness of course objectives and facilitating a positive learning environment, whether it be online, or in the classroom.. I have extensive knowledge of the D2L system and have a strong understanding of curriculum design and student evaluations.

Senior Management role, HR, budgetary requirements on the quarter, QA/QC, cGMP, ISO, PFOLA, SOP formulation, accreditation of lab, staff training practices within scope of ethics and professional practice GCP with implementation of Lean and Six Sigma philosophyCustomer Service, high interaction within multi-disciplinary system of surgeons, therapists, GPs, Chiropractors, Podiatrists, ChiropodistsEstablish and monitor clinical trials on medical orthotic devices & marketing for vast industry competition including the introduction, education, training, marketing and application of additive manufacturing of the Premier Orthotics Lab Line of F3 3D printed orthotics.

Orthotic consultation for technical & clinical clarity on site as well as off site.

Phase I Oncology (Bladder, Melanoma, Colon) clinical trial Phase II Diabetes LDL-C clinical trialPhase II Dermatological Diabetic Ulcer clinical trialPhase IV study (Survey: Proper Use and Cost Reduction Strategies for Prescription and Non-Prescription Drugs)Member of the clinical development teamReviewed protocol requirementsDrafted appropriate CRFs, IBs, CFs and SOPsMeticulously researched and selected potential investigative sitesDeveloped study timelines and detailed plan of studyDeveloped templates for study initiation deliverables (checklists for site evaluation, initiation, monitoring, close-out; subject screening & recruitment, visit logs and drug accountability logs).Direct exposure to clinical trials SOPs and formsTrained to perform Pre-Study, Initiation, Interim Monitoring and Close-Out visits according to applicable SOPs, FDA regulations and ICH GCP guidelines.Issued letters of agreement/contractsValidation of inclusion/exclusion criteria and evaluation of patient enrollmentReporting of adverse events in compliance with IRB stipulations and in accordance with FDA regulations and ICH guidelines

Clinical and technical training, SOP development, QA/QC of dispensed product and orthopedic footwear.

Senior Management Role, QA/QC, cGMP, ISO PFOLA consisting of staff training, SOP formulation, audit trails, software development, order invoice, budget inventory control, customer support services, 7 satellite clinic maintenance, management and supportInside/outside sales retention, development, support and reactivation

Member of the medical physics & patient treatment planning mould room department for radiation treatment planning.

patient assessment, education, casting, fabrication, design, fitting, follow-up and support/care, clinical trials