Industry Consultant


  • GCP/Quality Assurance Audits involving pharmaceuticals, medical devices and biological clinical trials
  • For-Cause, Due Diligence, Gap Analysis and Inspection Readiness Audits
  • Vendor Audits including CROs, Data Management, Diagnostic Imaging and Quality Management Systems
  • GLP Audits of Central and Specialty Labs (CLIA, CAP)
  • BIMO Inspections
  • Corrective and Preventive Action (CAPA) Development and Review
  • SOP Development


  • Extensive knowledge of FDA 21 CFR Parts 11, 50, 54, 56, 312 and 820 compliance and enforcement policies; GDP, GCP, GLP, ISO 14971 and ISO 13485 requirements; ICH E6(R2) guidelines; and ex-US regulatory procedures governing the conduct of clinical studies, including Health Canada, European Medicines Agency (EMA), Ministry of Health of Ukraine (MOH), Ministry of Health in Argentina (ANMAT), Brazilian Regulatory Agency (ANVISA), Instituto de Salud Pública de Chile (ISP), Australian Therapeutic Goods Administration (TGA) and Singapore Medicines Act.
  • Extensive experience in auditing of national/international clinical trials
  • Sound ability to prioritize and understand work impact and to work under pressure and independently
  • Excellent communication and interpersonal skills
  • Speak (conversational) and read French; read Portuguese and Spanish
  • No travel limitations; current US passport



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:

  • Senior Quality Assurance Consultant, Nov 2019 – present
  • Massachusetts-based pharmaceutical company: Conduct global GCP vendor audits (CROs, Phase I Units, Laboratories, Imaging facilities) for ongoing clinical trials
  • Senior Quality Assurance Consultant, Mar 2013 – Jun 2015, Jun 20/16 – present
  • Pennsylvania-based consulting group: Conduct North American GCP investigator site and vendor audits; SOP development: CAPA development and review
  • Senior Quality Systems Consultant, Feb 2011 – present
  • Massachusetts-based pharmaceutical company: Conduct global GCP investigator site audits for multi- therapeutic clinical trials; perform Inspection Readiness Audits
  • Clinical Quality Assurance (CQA) Consultant, Mar 2013 – Jul 2014
  • Massachusetts-based pharmaceutical company: Assisted in the development of audit plans; maintained standardized metrics of audit observations and trends; conducted investigative site and vendor GCP audits; served as co-auditor for ex-US GPV audits; interfaced with Clinical Operations pre- and post-audits; supported inspection readiness activities; assisted in deviation and CAPA management, to include tracking, trending and monitoring audit observations through resolution, ensuring proper root cause analysis is being performed, and ensuring that management is made aware of overdue or ineffective CAPA; and maintained cross-functional communication between Quality Assurance, Clinical Operations and Drug Safety
  • CQA Consultant, Mar 2003 – Dec 2013:
  • Pennsylvania-based University: Audited oncology and HIV investigator-initiated gene therapy and vaccine clinical trials
  • GCP Auditor, May 2011 – Oct 2013:
  • Illinois-based pharmaceutical company: Conducted US and ex-US GCP audits for acute renal failure/dialysis; performed Inspection Readiness Audits
  • Senior GCP Consultant, Jun 1997 – Dec 2010:
  • Global CRO: Worked with domestic and foreign clients in the pharmaceutical, medical device, and biotechnology industries to conduct GCP audits and manage and develop quality assurance and regulatory strategies for compliance with regulatory requirements.


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.



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



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.



New York State Registered Professional Nurse, License #213245



  • 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

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