DEBORAH BALDWIN

Deborah.Baldwin2008@gmail.com www.linkedin.com\n\deborahbaldwin2008

h: 215-457-1395 / c: 267-971-9059

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, Womens Health, Pain, Device, Infectious Disease, Cardiovascular, Urology, Immunology, Vaccines, Renal Dialysis, Anticoagulation, CNS/Neurology

PROFESSIONAL EXPERIENCE
UNIQUE AID SERVICES, Lansdale, PA 08/2013 to Present 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 clients need change overtime. Services may include but not limited to: Transporting patients to perform errands, cooking, cleaning, hygiene assistance, dressing assistance, medical equipment maintenance and assistance, changing catheters, assisting with medication, assisting client to medical facilities, conducting and participating in clinical research activities. 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 sitelevel 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

DEBORAH BALDWIN
deborah.baldwin2008@gmail.com

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Study File Analyst (Contractor) Hired to assist pharmaceutical, drug, and device companys 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 Clinical Research Associate (Contractor) 10/2004 to 03/2005

DEBORAH BALDWIN
deborah.baldwin2008@gmail.com

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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 SAEs from CRFs 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 reportin g SAEs and AEs. 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 IIV Drug Safety Training INC Research Trainings GCP and IHC Foundations and Core Clinical Practices Barnett International Overview of Clinical Research Phase IIV

PROFESSIONAL AFFILIATIONS
Association of Clinical Research Professionals (ACRP) Philadelphia Chapter Program & Evaluation Committee

COMPUTER SKILLS
CTMS Impact Oracle Clinical EDMS EDC IVRS MS Office