DANIELLE M. POWELL, RN, MS

** ********* *****

Loudonville, NY 12211

518-***-**** cell

acgefn@r.postjobfree.com

EXPERTISE

< GCP Audits of Sponsor/CRO, Vendor, Clinical Investigator, IRB,

Trial Master Files and GLP Audits of Central and Specialty Labs

(CLIA, CAP)

< Due Diligence Audits

< Quality Systems Development/Implementation

< Corrective and Preventive Action (CAPA)

< Training

< SOP Development

< Management of Clinical Trials

SPECIAL QUALIFICATIONS

. Extensive experience in GCP auditing and monitoring of

national/international clinical trials, including Phases I-IV multi-

therapeutic drug and device trials

. Experience in conducing GLP audits including facility audits, process

and study audits, chain of custody, study plan and report reviews, and

computerized systems; and assisting in ex-US GPV audits

. Extensive knowledge of FDA compliance and enforcement policies and ex-

US regulatory procedures governing the conduct of clinical studies

. Experience with electronic data capture and electronic

randomization/drug assignment systems

. Sound ability to prioritize and understand work impact and to work

under pressure and independently

. Excellent communication and interpersonal skills

. Speak and read French; read Portuguese and Spanish

. No travel limitations; current US passport and active Brazilian work

visa through 2015

PROFESSIONAL EXPERIENCE

QA Auditor III

PPD, Inc.; home-based, Glenmont, NY 12207; 07/2014-present

Assesses company activities to assure that contractual obligations to

client companies are 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; acts as a knowledgeable

CQA and GCP resource/consultant to operational departments; and mentors

junior auditors in agreement with CQA Management.

Independent Consultant

DPA, Inc.; Glenmont, NY 12077; 11/96 - present

Collaborate with pharmaceutical, biotech and device companies to provide a

leadership role in clinical affairs direction, project management, and

quality assurance auditing of clinical drug, device and delivery trials in

the United States, Canada, Europe and South/Central America.

Recent contracts:

. CQA Consultant, 03/2013 - 07/2014: Massachusetts based pharmaceutical

company: Assist in the development of audit plans; maintain standardized

metrics of audit observations and trends; conduct investigative site, CRO

and vendor GCP audits; served as co-auditor for ex-US GPV audits;

interface with Clinical Operations pre- and post-audits; support

inspection readiness activities; assist 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 maintain cross-functional communication between Quality Assurance,

Clinical Operations and Drug Safety

. CQA Consultant, 07/2012 - 07/2014: Pennsylvania based clinical quality

assurance consulting firm: Conduct GCP audits of multi-therapeutic

clinical trials and GLP audits of central and specialty labs

. CQA Consultant, 03/2003 - 12/2013: Monitor and audit University-based

oncology and HIV investigator-initiated gene therapy and vaccine clinical

trials

. GCP Auditor, 05/2011 - 10/2013: Chicago based pharmaceutical company:

Conducted US and Central America GCP audits for acute renal

failure/dialysis

. Senior Quality Systems Auditor, 02/2011 - 6/2012: Massachusetts based

pharmaceutical company: Conducted global GCP audits for multi-therapeutic

clinical trials

. GCP Auditor, 02/2010 - 05/2010: Santa-Rosa based CRO: Conducted

Investigative site audits for a pivotal safety and efficacy study of

embolization device in endovascular treatment of uncoilable intracranial

aneurysms; assisted in inspection readiness activities at Investigative

sites

. Senior GCP Auditor, 1997 - 2010, Rockville, MD 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.

Director of Clinical Affairs

Trivascular, Inc.; Santa Rosa, CA; 01/2009-01/2010

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 are 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 physicians

and nurses; 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; 05/96-11/96:

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)

Association of Clinical Research Professionals (ACRP)

. Regulatory Affairs Professionals Society (RAPS)

. 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

PERSONAL

. Married 40 years to Richard W. Powell, Detective APD

(Retired)

. Four children: Lt. Col. Nicole Powell-Dunford, MD, Flight Surgeon; US

Army; Fabienne Powell, MA; Captain Max Powell, USCG certified; and Major

Richard W. Powell II, US Army

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