Patricia Ayers Email & Phone Number

▷ Senior clinical research professional with 30 years’ hands-on experience in full-cycle clinical trial execution: Clinical research SME with Master of Science in Clinical Research Administration and a dynamic medical background that includes serving in the US Navy, leading multiple clinical trials that successfully achieved PMA, 501(k), CE, and IDE approvals, and consultancies that assisted clients in passing TUV audits. ▷ Collaborative leader and exceptional communicator: Aptitude in clinical research and exceptional written and verbal communication combined with demonstrated competency to collaborate with diverse stakeholders in a respectful, equitable, and inclusive fashion creates fluid environments that enable people to focus on goals and results.▷ High-performance motivated clinical affairs specialist: Driven professional with a dedicated work ethic and passionate enthusiasm for driving innovative medical devices through the clinical trial phases, gaining approvals, and on to commercialization. Demonstrated success in owning the entire process of clinical trials, including site identification, selection, and initiation, constructing and leading teams, supporting trial activities, managing budgets, and final close-out.Career Highlights Include:➤ Over 24-years of experience with medical devices, 15-years in clinical trial research, 8-years within a Cath lab and ICU environments, 4-years’ experience at biotech companies, and 3-years with neurostimulation devices➤ Led and conducted clinical studies, including preparing and submitting documents, that were granted three PMA approvals, eight 501(k) approvals, two CE Mark approvals, and six IDE approvals for various medical devices➤ Comfortable recruiting, hiring, and training clinical staff of all levels, with 6-years’ experience developing departments, teams, and personnel for clinical trials, start-ups, and various healthcare clientsSpecialties: Protocol development, SOPs, site initiation, monitoring, close-out, Clinical Report writing, IDE studies, GCP, FDA regulations, EUMDR, MDD regulations, PMA submissions, medical writing, primarily for medical devices and biotech.

Listed skills include Regulatory Affairs, Clinical Trials, Medical Devices, Clinical Research, and 13 others.