1. Stacy H. Flannery
801 Neuse Ridge Drive ● Clayton, NC 27527 ● 919-745-7469 ● sflannery0225@gmail.com
Summary/Highlights of Qualifications
 Expert Study Coordinator for Phase II and III otology/neurotology drug and device studies
 Experienced clinical trials monitoring team member; adept at site and sponsor facing query management and
reporting, systems/data management and PI support
 Regulatory document specialist; IRB submissions, site start-up
 Analytical problem-solver; skilled at anticipating and identifying opportunities for systemic and operation efficiency
 Self-motivated and organized professional with strong communication skills; effective both independently and as
part of a cross-functional, multi-time zone team
 Clinical Trials Systems: iMedidata (Rave, EDC, Balance & Reporter), CTMS, IVRS/IWRS/IXRS, Inform,
Firecrest ICON, EDC
 Clinical Research Training/Certifications: CITI ICH-GCP, Human Research Protections; C-SSRS (see
training transcript)
 Therapeutic Areas: Oncology, Diabetes, CNS, Auto-Immune Disorders, Otology/Neurotology
(Meniere’s Disease, ETD, Cochlear Implant, Osseointegrated hearing devices)
 Knowledge: ICH GCP, FDA GCP, 21 CFR, IRB/REB submission
Professional Experience
Clinical Trials Assistant (2016-present)
CTA Lead; CTA Mentor; Job Shadow for new Early Talent Acquisition employee
• CTA Lead for team handling project with multiple protocols, more than 70 sites US & Canada, project leadership
outside US – recognized for project management, communication, and leadership skills
• CTA Mentor (junior CTAs) / Job Shadow (new hires) – recognized for training of junior staff
• Accurately update and maintain clinical systems that track site compliance and performance with project timelines
• Assist clinical team in preparation, handling, distribution, filing and archiving of clinical documentation and reports
according to the scope of work and standard operating procedures
• Manage the regular and periodic review of paper and electronic study files for completeness
• Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
• Act as a central contact for the clinical team for designated project communications, correspondence and associated
documentation; serve as country expert for project teams
Clinical Research Coordinator (2007-2016)
• Manage on site specifics for multiple studies – protocol development process, informed consent procedures, drug
administration process, screening and enrollment visits/process (inclusion/exclusion checklists), components of
protocol visits (assessments, con meds, study drug compliance, lab testing and review, adverse event reporting, case
report form completion and data entry), blinding and unblinding procedures, management of subject scheduling and
patients lost to follow-up
• Manage regulatory documents including FDA 1572, financial disclosures, clinical trial agreements, disclosure
agreements, IRB submissions and approvals (including rosters, amendments/renewals, safety reports), lab
certificates
• Ensure proper study staff training/compliance, maintain site visit and training logs, maintain staff credentialing and
training records

2. Other Previous Experience
Regulatory Associate (2014-2015)
• Format chemical composition/formula of cosmetic products for international submissions
• Research correct identification of trade name for proper listing utilizing trade resources
Project Manager (2010-2016); Executive Assistant (2007-2010)
• CME Coordinator – manage activity planning, course logistics, record-keeping and accreditation
• Meeting Planner – manage local, regional and national meetings – program development, venue and catering
contracts, brochure development and marketing, speaker engagement, registration and evaluation, record-keeping
and reporting
• Event Planner – direct annual camp for hearing impaired children – camper and volunteer registration and
assignment; activity planning and scheduling; theme, decorations and t-shirt design; corporate support; on-site
logistics for over 200 participants
• Travel Manager – handle national and international travel – flights, accommodations, transportation, activities
• Back-up Office Manager for CFO – supervise administrative staff and manage daily operations; experienced in health
care practice management and operations protocols, including human resources, HIPAA, front desk procedures,
patient demographics, surgery and treatment orders, prior authorization for in-patient and out-patient procedures,
evaluation and management coding and documentation requirements
• Health Care Policy Specialist – medical coding, including ICD-9, ICD-10 and CPT; prior-authorization of surgery and
office procedures; Medicare, Medicaid and commercial insurance benefits, coverage policies and reimbursement;
analysis of federal and state regulatory and legislative policies, including CMS, OIG, NCDHHS, Congress and the NC
General Assembly
• Credentialing Manager – professional credentialing for providers – hospitals, insurance plans
• Executive Administrative Support – scheduling, correspondence, confidential record-keeping, report and publication
editing and submission
Director of Legislative Affairs (1999-2007)
• Managed highly effective government relations program – state legislative and regulatory policy research, analysis
and development; budget negotiations including Medicaid funding; confident public speaker; technical writing
• Fostered important relationships with government officials – NC General Assembly, Governor’s office, Cabinet
officials and their agencies
• Built strong and effective grassroots lobbying effort and strengthened coalition lobbying efforts with other
statewide organizations; conducted statewide training and legislative updates
• Managed statewide disaster planning effort for long-term care facilities, successfully obtaining federal grant funding
and coordinating with state emergency management organizations
Public Policy Director (1998-1999)
Legislative Specialist (1996-1998)
Voter Registration Director (1993-1996)
Education
MA, Political Science, Marquette University, Milwaukee, WI
BA, Criminal Justice, University of North Carolina, Chapel Hill, NC