SPECIAL QUALIFICATIONS
PROFESSIONAL EXPERIENCE
Independent Consultant
DPA, Inc Nov 1996 – Nov 2015, Jun 2016 - present
Collaborate with pharmaceutical, biotech and device companies to provide a leadership role in clinical affairs direction, project management, and quality assurance auditing of national and international clinical drug, device and delivery trials. Audit contracts include, but are not limited to:
Associate Director, GCP Services
Advarra Consulting, formerly Falcon Consulting Group; home-based, Malvern, PA; Jun 2015 - Jun 2016
Assisted in the oversight of GCP Services provided to Clients pertaining to global compliance, quality assurance and clinical trial oversight; assisted in the supervision and allocation of GCP Services resources relating to Client projects; established clear communication and workflow as Program Lead for individual projects; participated in client calls to obtain specifications for project proposals and agreements; developed agendas and facilitated Project Kick Off meetings with clients; developed Audit Plans with timelines for assigned client projects and monitored the appropriate submission of client deliverables; provided direction and guidance to project team members working on assigned client projects; performed quality oversight of assigned client work, including review of audit reports and other deliverables from team members; and conducted GCP and GLP audits on an as- needed basis.
QA Auditor III
PPD, Inc.; home-based, Glenmont, NY 12207; Jul 2014 – Jul 2015
Assessed company activities to assure that contractual obligations to client companies were met and conducted and reported in accordance with ICH Guidelines, regulatory requirements, and relevant PPD and client procedural documents; full responsibility for planning and delivery of quality programs for contracted quality assurance audits; acted as a knowledgeable CQA and GCP resource/consultant to operational departments; and mentored junior auditors in agreement with CQA Management.
Director of Clinical Affairs
Trivascular, Inc.; Santa Rosa, CA; Jan 2009-Jan 2010 [Contractual basis]
Contributed to strategic planning for this start-up company to ensure optimized clinical development plans for
assigned projects; managed clinical device trials; provided direction and mentorship to staff including setting goals that aligned with both Corporate and project goals; built, managed and maintained high performing clinical teams; provided direction and leadership in CRO and vendor selection and management; provided technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct; coordinated closely with all departments within the company; accountable for identification, assessment and communication of potential safety signals; developed relationships with and captured device safety information from investigative sites; collaborated with Regulatory Affairs to ensure appropriate reporting of safety information to regulatory agencies and prescriber community; prepared clinical research budgets and timelines; approved clinical monitoring plans and prioritized study monitoring needs; analyzed and developed action plans to address issues with investigational sites, CRAs, and CROs.
Project Manager, Clinical Operations
The Hardardt Group; Parsippany, NJ 07054; May 1996 – Nov 1996:
Management of multidisciplinary project teams to assure for the accurate and timely completion of all contracted activities. Responsibilities included design/implementation of project plans; serving as the primary liaison with the sponsoring company and internal operational units; supervision of clinical research teams and associated support staff; management of contract requirements for each assigned project and identifying/ responding to out-of-scope work requests; ongoing management of budget compliance through project completion; identification of specific client needs; preparation of progress reports and executive summaries; clinical monitoring and quality assurance auditing on an as-needed basis.
Senior Clinical Research Manager, Oncology/AIDS Program
Coromed, Inc.; NY 12180; 1994 – 1996
Development and management of the newly formed Oncology/AIDS Program, including business development; preparation of proposals and presentations to clients; preparation of clinical agreements, including budget negotiation and grant management; development of protocols specific to particular clinical trials; assisting sponsors with preparation and submission of INDs and NDAs; representing Coromed at symposia and professional conferences.
Clinical Project Manager, Cardiovascular Program
Coromed, Inc.; NY 12180; 1992 – 1994
Management of ongoing cardiovascular clinical trials to ensure for completion of all contractual activities, including supervision of CRAs; identification, selection and investigation of sites for placement of trials; development of case report forms, monitoring tools and study guides specific to particular clinical trials; and operations management, coordination, auditing and monitoring cardiovascular clinical trials in accordance with GCP, current FDA guidelines, and client SOPs.
Clinical Research Associate, Cardiovascular Program
Coromed, Inc.; NY 12180; 1991 – 1992
Monitoring of cardiovascular investigational trials in accordance with GCP, current FDA guidelines and client SOPs; managing daily and long-term clinical study activities; site management and training; performing site initiation, routine monitoring and close-out visits; maintaining drug accountability; assuring for the timely reporting and recording of serious adverse events; reviewing, clarifying and processing of case report forms and other scientific material within contract-defined time constraints.
Clinical Research Coordinator, Oncology/AIDS
Albany Medical College; Division of Medical Oncology; Albany, NY 12206; 1984 – 1991
Evaluated, screened and enrolled qualified subjects into Phase I-IV pharmaceutical-sponsored and in-house AIDS and oncology clinical trials; clinically assessed enrolled subjects; conducted clinical trials in strict compliance with GCP; completed case report forms in a timely manner; and analyzed and evaluated in-house clinical trials data to determine efficacy and safety.
Nursing Supervisor
VA Medical Center; Albany, NY 12210; 1976 – 1980
Clinical supervision and management of nursing practice, quality assurance, and staff development in a 160-bed facility; orientation and training of part-time weekend nursing staff on rotating day and night shifts; accountable for all final medical nursing decisions made on tours of duty; preparation of staffing schedules, periodic auditing of medical records, and participation in Utilization Review Committee meetings.
Staff Nurse:
VA Medical Center; Albany, NY 12210; 1968 – 1976
Primary nursing care in medical and intensive care units, including cardiology, neurology, pulmonary and oncology; charge duty on evening and night shifts for approximately 20-30 staff members.
EDUCATION
MS: Urban and Environmental Studies
Rensselaer Polytechnic Institute, Troy, NY, 1990
Areas of concentration: Health Care Policy, Research Design, Sociology of Medicine, Medical Ethics
Graduate Thesis: A Comparative Analysis of Skilled Nursing Facility Standards and Maximum Secure Prison Standards Under Goffman’s ‘Total Institution’ Model
Research Assistantship, 1989-1990: National Institutes of Health, Washington, DC – A Bibliometric Analysis of Alzheimer’s Disease
Association Fellowship, Spring 1990: Albany Medical College, Albany, NY – Medical Morality in Death and Dying
Managing Editor, 1988-1990: Science, Technology and Human Values, Journal of the Society for Social Studies of Science
BS: History/Biology
Union College, Schenectady, NY; 1987
Areas of Concentration: Development of Modern Medicine, Biomedical Ethics, Scientific Revolution
Senior Thesis: A Historical Review of the Effects of Cannabis in Medicine
AAS: Nursing
Hudson Valley Community College, Troy, NY; 1968
PUBLICATIONS
Remick, SC, McSharry JJ, Wolf C, Blanchard C, Eastman AY, Wagner H, Portuese E, Wighton T, Powell D, Pearce T, Horton J, Ruckdeschel JC. Novel oral combination chemotherapy in the treatment of intermediate- grade and high-grade AIDS-related non-Hodgkin’s lymphoma. Journal of Clinical Oncology 1993; 11: (9) 1691- 1702.
LICENSURE
New York State Registered Professional Nurse, License #213245
PROFESSIONAL ORGANIZATIONS
American Society for Quality (ASQ)
Florence Nightingale Association
New York State Nurses Association (NYSNA)
Medical Resource Corps (MCR) for NY State, sponsored by NYS DOH to provide skilled medical assistance in time of disasters