Scottsdale, Arizona, United States
Seasoned Clinical Research Professional with over 15 years of progressive experience managing and leading multifaceted clinical trials across neurology, immunology, and rare diseases. Adept at designing and executing clinical research programs, ensuring compliance with FDA, ICH/GCP, and global regulatory standards. I thrive on fostering cross-functional collaborations to achieve organizational goals while advancing clinical innovation. Expertise includes: - Leadership in investigator-initiated trials - Site operations and SOP implementation - Budget management and process optimization - Regulatory and quality compliance (FDA, ICH/GCP) - Neurology and rare disease research I have managed multimillion-dollar clinical trial budgets and spearheaded initiatives that streamlined processes and improved outcomes. My work spans therapeutic areas such as ALS, MS, Parkinson’s disease, Myasthenia Gravis, and other rare diseases. Recognized for building high-performing teams and driving operational excellence. Let’s connect to explore opportunities to advance clinical research and improve patient outcomes. Publications: Gibbons CH, Levine T, Adler C, et al. Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients With Synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792
Home of the Sync-ONE Test3 Directed multi-site clinical trials from initiation to closeout, ensuring adherence to regulatory standards. Reduced study startup time by 20% through process improvements. Oversaw $10M+ annual budgets and provided executive-level updates. Key Achievement: Spearheaded the launch of the Syn-One Test for early Parkinson’s diagnosis.
Implemented clinical trials aligned with Dignity Health objectives. Coordinated regulatory documents and protocol adherence. Actively recruited, screened, and retained study participants. Ensured compliance with Good Clinical Practice standards.
This position is responsible for the day-to-day management of clinical project activities and resources and overall clinical data and protocol management for the conduct of therapeutic clinical trials at HonorHealth. Provides data management project leadership to support multi-disciplinary clinical trials, including patient screening for study eligibility, obtaining Informed consent and subject registration. Prepares annual reports and statistical information on all clinical research as required by System, IRB or investigators. Collaborates with Regulatory/IRB Coordinator. Track study/clinical trials progress and issues periodic status reports. Communicates the achievement of key milestones such as draft or final database to the project team. Provides assistance to peers to ensure that study deadlines are met. Identifies data management project issues and alerts senior department management with a view to recommendations. Maintains communication with supervisor regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices. Acts as liaison in support of pharmaceutical and investigator initiated clinical protocols. Participates in site initiation, interim monitoring, and study close out visits with sponsor and FDA initiated audits. Participates in mentoring and training of staff on data management procedures, and systems, including the mentoring of all direct reports.
Led multiple protocols and managed regulatory documentation. Acted as liaison for site selection, initiation, and participant recruitment. Ensured compliance with Good Clinical Practice standards.