Clinical Research and Regulatory Affairs

Deborah Baldwin h: 215-***-**** / c: 267-***-****

*******.***********@*****.***

www.linkedin.com\n\deborahbaldwin2008

Clinical Research Associate

Site Management ( IND Submissions ( Protocol Review ( Quality Assurance (

Data Monitoring & Analysis ( Drug Safety

Study Start-up ( Trial Master File Auditing ( GCP & ICH Compliance (

Product Accountability ( UADE Response

Highly knowledgeable and progress-driven Clinical Research Specialist with

10+ years' experience in clinical monitoring, regulatory affairs, and data

management in the medical device and pharmaceutical industries. Deliver

practical solutions to desired client requirements within world-class

organizations. Demonstrate high level of leadership, initiative, and

problem-solving skills in complex scientific research environments.

Exceptional written, interpersonal, and public speaking skills.

Therapeutic Areas: Oncology, Women's Health, Pain, Device, Infectious

Disease, Cardiovascular, Urology, Immunology, Vaccines, Renal Dialysis,

Anticoagulation, CNS/Neurology

Professional Experience

Unique Aid Services, Lansdale, PA 08/2013 to 02/2014

Patient Care Specialist (Contractor)

Responsible for providing quality in-home support with one-on-one care and

services for patients and children with special needs. Work with clients

and their families to fulfill request for consumer cases. Develop strong

client relationship with ongoing assessments to focus services with goal of

fulfilling needs and making ongoing recommendations as client's need change

overtime.

CLINSMART, Langhorne, PA 01/2013 to 6/2013

Clinical Research Associate (Contractor)

Reviewed scientific sections encompassing pharmacology, toxicology, and

pharmacokinetics for 3 IND submissions per sponsor request. Assisted with

developing IND clinical study reports including for regulatory submission.

Performed in-house and onsite monitoring activities for 4 protocols. Aided

project team with preparing for audits/inspections, ensuring quality and

completeness of clinical study documentation for TMF filing. Compiled study

binders and site visit packets prior to site initiation. Participated in

selection and oversight of vendors to achieve project goals.

. Worked closely with site personnel to clarify protocol-specific questions

and update regulatory study documentation for 4 protocols.

. Collaborated with Regional Clinical Research Associate to discuss trial

issues across all study sites in regards to site performance and metrics.

ICON CLINICAL RESEARCH INC. /ICON TEMPS, North Wales, PA 07/2012 to

09/2012

Clinical Trial Associate (Contractor)

Enlisted by former employer to support special project for sponsor internal

FDA audit, including selection of protocol, country, and site-level

documents. Ensured consistency, completeness, and adherence to standards

for all regulatory documents selected for audit.

. Verified 250 documents in Elara and DMV databases with comment or

resolution.

charter school services, Philadelphia, PA 10/2009 to 11/2011

Substitute Teacher (Contractor)

Provided H1N1 education to 800 elementary, middle, and high school students

within charter school. Designed and reviewed scientific lesson plans and

served as substitute teacher for other subjects as needed.

. Mentored 250 special needs and foster care program individuals.

. Selected as panel judge for AmeriCorps Youth Build Program essay contest

for graduating students.

pfizer PHARMACEUTICALS, Collegeville, PA 05/2010 to 12/2010

Study File Analyst (Contractor)

Hired to assist pharmaceutical, drug, and device company's Study File

Management Department with internal and FDA audit preparation, site

initiations, and TA releases. Reviewed regulatory documents for 6 sites and

resolved discrepancies from past/present clinical trials. Updated IND

submissions and prepared clinical trial transition forms. Liaised between

Regional Study Managers, Study Teams, and Clinical and Regulatory

departments.

. Directed study start-up activities for non-IND psoriatic arthritis study

with 1K patients.

. Expedited initiation-readiness for 30 sites and received commendation for

excellent performance.

. Completed 80% of document finalization prior to project

outsourcing/transfer to contract research organization.

GE HEALTHCARE, Waukesha, WI 09/2008 to 08/2009

Regional Clinical Research Associate (contract assignment through Kelly

Services)

Identified and verified reporting of adverse events, 5 UADEs, and protocol

deviations. Contributed to development of study-specific monitoring tools

and necessary documents. Completed site initiation and trained staff on

protocol, research design, study requirements, and device operation.

Analyzed case report forms (CRF) and source documents for consistency,

scientific validity, and compliance.

. Reviewed/audited data used in final clinical study report that later

achieved publication.

. Earned reputation as true business partner and project leader.

inc research, Raleigh, NC 05/2007 to 06/2008

Regional Clinical Research Associate (Contractor)

Conducted periodic monitoring of clinical study sites from screening and

initiation to study closure. Monitored 12 sites and 4 protocols, ensuring

data accuracy, investigator integrity, and protocol/regulatory compliance.

Responsible for site management activities including in-house and on-site

monitoring; pre-study, initiation, interim, close-out visits, and site

visit reports. Resolved deviations and outstanding queries. Devised and

implemented improved study methods and drafted written summaries for

management.

. Boosted monitoring task productivity by 65% and completed all trip

reports for 4 protocols.

. Resolved 1.5K data discrepancies and achieved 65% of required patient

enrollment at each assigned study site.

Merck & Company, inc., North Wales, PA 07/2006 to 03/2007

Adverse Event Coordinator (Contractor)

Analyzed non-serious and serious adverse events for various studies in

oncology, neurology, cardiovascular, HIV/AIDS, and pain. Ensured immediate

processing of expedited cases with FDA requirements. Drafted descriptive

narratives for vaccines, infectious disease, and cardiovascular products.

. Reviewed more than 300 non-serious adverse events for vaccine study;

results used for final safety analysis.

. Processed 65% of all adverse events within 24- and 72-hour timeframes.

Clinical Monitoring Specialist (Contractor) 07/2006 to 03/2007

Ensured sites adhered to AE/SAE reporting procedures and reviewed reports

prior to submission to Drug Safety Department. Addressed issues between

sites and Data Management Department. Communicated effectively between

Medical Monitor, Senior Clinical Specialist, and site personnel.

. Resolved 1K+ discrepancies for Phase III/Phase IV HIV clinical trial

study.

. Key player in development of final clinical study report; completed

medical reviews of labs, medications, ECG, and histories.

Mercer staffing, inc., Plymouth Meeting, PA 10/2005 to 06/2006

Therapeutic Support Staff (Contractor)

. Provided one-on-one intervention with clients according to treatment

plan.

. Supervised client activities; assisted client to improve behavioral

health and create positive community adaptation.

covance, inc., Radnor, PA 10/2004 to 03/2005

Clinical Research Associate (Contractor)

Responsible for addressing unresolved protocol issues with various sites;

Trained sites on Interlinks for submission of regulatory documents;

Submitted pre-study questionnaires to project manager in order to review

for drug shipment; Identified process efficiencies to improve site

performance and increase enrollment rates.

. Decreased study timeline by 50% through improved site performance and

increased enrollment rates.

. Resolved 100+ protocol issues per week for 30 sites.

. Trained staff on Interlinks to improve organization and submission of

regulatory documents to institutional review board.

sanofi-aventis, Bridgewater, NJ 06/2004 to 09/2004

Global Regulatory Associate (Contractor)

Collected and prepared information from various members of the project team

for IND submissions; Reviewed final drafts of regulatory documents to

ensure compliance and consistency; Attended Project Team and other related

meetings.

. Completed IND submissions; reviewed 3 final regulatory document drafts

for compliance and consistency.

teva neuroscience, North Wales, PA 10/2003 to 03/2004

Regulatory Document Specialist (Contractor)

Reviewed and audited regulatory documents to ensure consistency with the

investigator site binders. Prepared reports to identify outstanding

regulatory issues. Audited study files to ensure proper documentation for

closeout.

. Audited 25 regulatory documents and more than 40 study files; prepared 30

regulatory reports.

elan pharmaceutical, Princeton, NJ 09/2002 to 03/2003

Clinical Research Associate (Contractor)

Compared Radiographic reports from base line to completion of study to

determine disease progression (Gallium, CT, Bone Scans, MRI, X-Ray, and

Ultra-sound). Reviewed source documentation to determine inconsistencies

against the CRF. Resolved issues and generated the necessary queries.

Verified the accuracy of SAE's from CRF's in conjunction with the Medwatch

report. Interacted with the Director of Clinical Research and other team

members to resolve laboratory discrepancies and toxicity grades for

reporting SAE's and AE's.

. Analyzed more than 1K radiographic reports; improved adverse event

reporting progress by 65%.

wyeth pharmaceuticals, Collegeville, PA 07/2002 to 08/2002

Global Regulatory Associate (Contractor)

Interacted with the Clinical Scientist on global Oncology study in order to

resolve outstanding issues to reconcile domestic and international study

files. Audited all internal regulatory documents for any inconsistencies.

Provided follow up letters to inform sites of outstanding documents

required to reconcile the study files.

. Reconciled 425 issues in 2K+ study files; increased study productivity by

67%.

Education & Professional Development

B.S. in Biological Science, Temple University, Philadelphia, PA

GE HealthCare Medical Device Clinical Trial Training

Merck & Company Overview of Clinical Trials - Phase I-IV Drug Safety

Training

INC Research Trainings - GCP and IHC Foundations and Core Clinical

Practices

Barnett International Overview of Clinical Research Phase I-IV

Professional Affiliations

Association of Clinical Research Professionals (ACRP)

Philadelphia Chapter Program & Evaluation Committee

Computer Skills

CTMS ( Impact ( Oracle Clinical ( EDMS ( EDC ( IVRS ( MS Office

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