23+ years of clinical research experience.
Clinical Trial Design, Implementation, and Management; Clinical Operations; Clinical Research; Monitoring; Site Development; Clinical/Regulatory Guidance; Study Lead; Project Management; Writing- Protocols, SOPs, CRFs, Business Plans, Budgets, Operational Timelines, and Mission Statements; Investigator/Coordinator Training.
Product Research and Development Consultant, Ergogenic Research, Inc.
Provide CRO and individual services: establish research programs, identify and resolve operational issues, design and implement clinical trials, manage projects, and perform monitoring and site development. Provide clinical/regulatory guidance to establish research studies for an LED manufacturer developing a hand-held, over-the-counter device for home use, in preparation of a 510(k) SE submission. Designed and running a feasibility study to determine product pathway.
Clinical Operations Director, Ergogenic Research, Inc.
Assisted a small biotech company by establishing a Clinical Operations Group, writing SOPs, and hiring and managing staff and all clinical vendors. Wrote protocols, designed CRFs and all study-required documents as well as established and managed a CSCC (Clinical Study Steering Committee) and DSMB (Data and Safety Monitoring Board). Directed the clinical development of a multi-marker lab assay and bench device, and assisted with a clinical study report and 510(k) submission for a pediatric study. Developed study plans, wrote protocols, and implemented and managed four successful studies in 3.5 years. Senior/Lead CRA for variety of projects including a study for psychosis in Parkinson’s disease, implanted oncology pain pump, CRA training across multiple studies, multiple Phase 1 female hormone studies, pulmonary hypertension study, and multiple studies supporting Aricept.
Senior Project Manager, PPD Development
Clinical trial management including RFP defense, Sponsor, CRA, and financial management as well as day-to-day study management.
Clinical Research Consultant, The Memory Clinic
Assisted with the design and implementation of an infrastructure that expanded clinic’s research capabilities beyond CNS trials. Responsible for securing projects and training coordinators.
Chief Operating Officer, Northeastern Trial Management Network
Established a network of research physicians in multiple therapeutic areas. Responsible for developing and writing the business plan, mission statement, and annual budget, and developing and maintaining an investigator database. Developed and implemented a service agreement for all physicians, SOPs, operational timelines, and marketing presentations. Other responsibilities included: securing studies from CROs and pharmaceutical companies, budget and contract negotiations, investigator/coordinator training, and establishing preferred provider relationships with Central IRBs and CROs.
Manager of Clinical Operations, Quintiles APS
Assured quality and consistency of monitoring services across clinical projects. Provided field training, coaching, and professional development for regional CRAs. Supervised all study clinical monitoring activities as well as site recruitment and grant negotiations. Responsible for timelines and all financial aspects, and success of studies for the Clinical Operations Department. Developed and implemented SOPs specific to late-phase research. Provided resourcing, financial, and feasibility input to Business Development group for proposals and represented the Clinical Operations Department at sponsor meetings.