Clinical Research Conduct, Audit, and Management Professional


Distinguished regulatory affairs professional specializing in regulatory strategic management with over 25 years of experience in Biologics & Advanced Therapy Medicinal Products, Prescription & OTC Drugs, Medical Devices and Cosmetics in areas such as:

  • Regulatory Strategy
  • Leadership / Management
  • Interactions with Health Authorities
  • CE Mark Technical Dossiers
  • Pharmacovigilance
  • IDE/510(k)/PMA Dossiers
  • Promotion/Advertising
  • New Product Introduction
  • ISO/MDR Compliance
  • GMP/QSR Compliance/Auditing
  • Due Diligence Activities

A distinguished professional with highly developed analytical, communication, organization and strategic planning skills who is committed to a high level of professional and personal excellence. A senior executive who has served as member of multiple executive leadership teams with extensive experience in building and leading global regulatory teams to fit organizational need.

Professional Experience:

Study Coordinator, Clinical Research Associate (CRA), Senior and Lead CRA, Research Manager, Clinical Program Manager, Director of Global Project Management, Principal Consultant, GCP Auditor, Head Project Management, Head Operations as a Full - Time Employee and a Consultant

GCP Quality Assurance, Auditing and Fraud Investigation:

  • Conducted multiple (89 as of the date of this document) GCP (prequalification and in-project) and due diligence audits of clinical sites, CRO and vendors in the United States, Latin America, Central and Eastern Europe
  • Conducted GCP audits of study documents and files
  • Assisted Sponsor companies and sites in preparation for the inspections by the Regulatory Authorities in the US and Europe through targeted audits and mock inspections
  • Led teams of international QA consultants and monitors on co-monitoring projects spanning 30 sites in 6 countries in Eastern and Central Europe
  • Participated in 3 suspected research fraud investigations

Monitoring and Management of Clinical Trials:

  • Managed all aspects of multiple Phase I, II and III clinical trial projects in the US, Latin America, Central and Eastern Europe and Russia in a variety of therapeutic indications for the US, Canadian and European clients
  • Supervised and trained in-house and contract project managers and monitors, assembled and managed successful project teams
  • Ensured trials are conducted on time, within budget and in compliance with Protocols, Standard Operating Procedures, FDA regulations and ICH GCP guidelines
  • Managed and conducted study start-up activities, site selection, budget negotiations, site training, initiation, routine monitoring and close-out activities
  • Participated in authoring of protocols, SOP, investigator’s brochures, informed consent forms, Investigational New Drug and New Drug Application submissions, interim and final study reports
  • Designed case report forms and produced study guidelines and manuals
  • Selected, managed and supervised Contract Research Organizations, central and local labs and other vendors

Operations, Business Development and Line Management:

  • Responsible for development and oversight of operational activities for the Contract Research Organization in North America which was recently rated number one CRO by the CenterWatch investigative sites survey second year in a row
  • Responsible for development of project management function in North and South America for international Contract Research Organization
  • Achieved 900% increase in the number of projects in operation and oversaw expansion from 10 to 180 full-time employees over four years
  • Responsible for oversight of recruitment, hiring, training, new employee orientation, conducting performance appraisals, and staff professional development
  • Responsible for development and implementation of individually tailored on- boarding processes and mentorship program to speed up and make team integration more efficient
  • Responsible for establishing and maintaining relationships with internal services and external clients
  • Participate in business development activities and presenting the Company capabilities to increase client base and obtain new business
  • Primary contact for the clients’ upper management for escalation and resolution of any operational and project related issues

Therapeutic Experience:

Medical and nursing background ensures capability to work successfully within any therapeutic indication

Recent therapeutic indication experience include –

  • Oncology – pancreatic cancer, small and non-small cell lung cancer, prostate cancer, bladder cancer, breast cancer, hematologic malignancies
  • Internal Medicine and Endocrinology – diabetes, sexual dysfunction, chronic pain, hematology
  • Infectious diseases – HIV, MRSA, cSSSI, HAP, CAP, UTI
  • Autoimmune diseases – rheumatoid arthritis, multiple sclerosis
  • Psychiatry/ Gerontology – Alzheimer’s disease


  • Taught a course in Clinical Research Monitoring at UCSC certificate program
  • Conducted training workshops at ACRP annual national conferences
  • Created training course materials and provided training in Basics of Clinical Research, GCP, Monitoring and GCP Auditing in the US, Eastern and Central Europe

Work History:

1/2015– current  Industry Consultant, San Francisco, CA

2012– 2015 PSI CRO AG, South San Francisco, CA

Head Operations, North America

2010 – 2012 PSI CRO AG, South San Francisco, CA

Head Project Management, The Americas

2004 - 2010 OSMOS Clinical Research, Inc., South San Francisco, CA

President, Principal Consultant

2001 - 2004 Cell Genesys, Inc., South San Francisco, CA

Senior and Lead CRA, Program Manager

1999 - 2001 Quintiles Pacific, Inc., Mountain View, CA

CRA, Senior CRA since 6/2001

1996 - 1999 Osmos International, Inc., Lowell, MA

Manager, Medical Device Research Group

1993 - 1996 UCSF Home Care, San Francisco, CA

Clinical Nurse II, Case Manager

1991 – 1993 Kentfield Acute Rehabilitation Hospital, Kentfield, CA

Clinical Nurse, Study Coordinator, Chronic Pain Clinical Research Program


MD - LSISH State Medical School, Leningrad, USSR

MS - State Naval Technical University, Leningrad, USSR RN – State Nursing School 6, Leningrad, USSR

Technical and language skills:

  • Computer proficient on Mac and PC with Microsoft Office software
  • Bilingual – English/Russian, Read - Ukrainian


US Patent 6261439

12 Commendation Awards for Excellent Nursing Care


Registered Nurse, active and current in California since 1991


Certified Clinical Research Associate (2002-2005), Certified Registered Rehabilitation Nurse (1993-1996)



Submit the form below to express your interest in this professional.