Project Manager Registered Nurse

Profile

Registered nurse with extensive clinical trial expertise and a

concentration in safety surveillance. Excellent clinical background and

analytical ability which enhance assessment and interpretation of medical

data as well as scientific writing. Knowledgeable regarding FDA and ICH

regulations and guidelines. Detail-oriented with strong skills in

organization, prioritization and process development. Ability to manage

multiple tasks and meet tight deadlines. Team player with an aptitude to

work independently. Creative with strong teaching/public speaking skills.

Professional Experience

2005 - 2012 Clinical Research Management, Inc.

Fort Detrick, MU.S. Army Medical Research and Material

Command/USAMMDA

Safety Process/Project Manager

. Assist in establishment of a safety infrastructure related to the

management of clinical trial safety data in Office of the Surgeon

General (OTSG), FDA regulated clinical research trials.

. Guide the development of safety language in establishing a standard

protocol template.

. Developed and implemented clinical safety standards and

processes including SAE Supplemental forms, SOPs and work practice

documents, medical assessment worksheets for case data and

narrative summaries as well as establishing processes to procure

outstanding case data and queries. Assist data management in the

development of standard AE/SAE CRFs.

. Responsible for the day-to-day oversight of Product Safety

Surveillance Department and handling of all immediately reportable

events.

. Initiated using the MedWatch Form 3500A to submit "Immediately

Reportable" events to the FDA. Drafted all 7/15 day safety reports

and ensured completeness and timely notification and reporting to

regulatory authorities. Developed a tracking tool for all

regulatory submissions.

. Manage CROs with regard to formulating initial business

agreements and performing oversight of all safety processes

including review of AE/SAE data and coding, as well as data

reconciliation.

. Prepare and present comprehensive training related to safety

procedures and forms including AE/SAE Reporting, Basic Medical

Coding and Safety Monitoring Plans.

. Collaborate with the Director of Data Management in the

implementation of a central coding dictionary and processes

including interviewing and selecting a vendor and development of

SOPs, coding guidelines and training of upper management.

. Coded adverse events using the MedDRA dictionary.

. Assist Product Safety Surveillance Branch, Regulatory Affairs

and Director of Data Management in the development of user and

functional requirements for an AERS and participate in the

identification and selection of an AERS. Participated in

validation of new safety database (Oracle/EmpiricaTrace).

Responsible for developing standardized processes for data entry,

and developing standard reports.

. Collaborate with the Contract department in review and

development of CRADA's and Safety Data Exchange agreements with

CRO's and other business partners.

2004 - 2005 Walter Reed Army Medical Center

Washington, DC

Independent Consultant

. Completed SAE submissions for Corporate Sponsor including chart

review, narrative summaries and retrospective CRF completion.

. Established and maintained Regulatory files.

. Advised regarding data display and assisted with generation of data

listings.

. QA 100% of study documentation and collaboration with PI regarding

findings and remediation.

. Assisted Principal Investigator with data review and

reconciliation in preparation for study reports.

1996 - 2004 MedImmune, Inc.

Gaithersburg, MD

Drug Safety Project Manager

. Real time medical assessment of AE and SAE reports including

assessment of relationship, causality, seriousness and time frame

for expedited reporting to regulatory agencies.

. Entry of AE / SAE data into Access and Clintrace databases as well

as clinical case review and writing comprehensive narrative

summaries of all events.

. Management of the evaluation and preparation of a high volume of

complex expedited serious adverse event reports for submission to

the FDA and European regulatory authorities.

. Review of study documents including protocols, informed consent,

CRF's, supplemental SAE report forms, investigator brochure and

final study reports as well as defining internal monitoring

procedures.

. Preparation and presentation of safety surveillance component at

Investigator Meetings and in-house training of AE/SAE reporting.

. Supervision of pharmacovigilance staff, both CRO and in-house,

including Drug Safety Monitors, Drug Safety Assistants and contract

personnel regarding safety surveillance of various phase I, II and

III studies including a large pediatric cardiac trial with 1,650

SAE's.

. Support endpoint review including assisting with reconciliation of

protocol specific data and provision of detailed medical case

summaries.

. Prepare, direct and document Medical Monitor safety review.

. Prepare and coordinate Safety Monitoring Committee, Advisory Board

and DSMB safety reviews.

. Support and collaborate with the Director of Investigational Drug

Safety to advise regarding project status including problem

identification, propose solutions and timeline management.

. Participation in data review including tables and listings

generated from the clinical trial database to identify safety

issues as well as manual reconciliation of the safety and clinical

trial database. Provide documentation of outcome and initiate

resolution of discrepancies.

. Interdepartmental collaboration including Information Technology,

Data Management and Biostatistics to procure special reports and

listings enhancing data review.

. Prepared and provide data to comply with reporting agreements of

corporate affiliates.

. Participated in departmental staff recruitment and hiring process.

1991 - 1996 Henry M. Jackson Foundation Rockville, MD

Research Protocol Coordinator

. Patient screening, education, counseling and recruitment.

. Coordination and implementation of phase I, II and III HIV drug

intervention, vaccine and natural history studies.

. Collection and maintenance of research data and QA of endpoint

data.

1987-1991 Suburban Hospital Bethesda, MD

Clinical Nurse II

. Coordination of the preoperative surgical process including

physical assessment, phlebotomy and pre-operative teaching.

. Coordination of the short-stay recovery and transfusion / IV

therapy unit for an outpatient population.

1985-1987 National Institutes of Health - NCI

Bethesda, MD

Clinical Nurse - Adult Medicine Branch

. Primary case management in clinical medical research involving

complex oncology patients.

. Administration of chemotherapeutic agents in clinical trials

involving solid tumors, leukemia's and lymphomas. Designed and

taught theory and clinical skills in Laminar Air Flow and bone

marrow transplantation.

Education

Diploma

St. Vincent Hospital School of Nursing

Erie, PA

Licensure

Registered Nurse in Maryland and Pennsylvania

Professional Affiliations

. Drug Information Association (DIA)

Awards

Sustained Superior Performance Award

Henry M. Jackson Foundation

April 1996

Chairman's Award

MedImmune, Inc.

January 2000

Exemplary Sustained Performance Award

Clinical Research Management, Inc. /USAMMDA

August 2010

Security Clearance

National Agency Clearance

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