Medical Quality Assurance

OBJECTIVE

I am seeking a challenging and dynamic position in Pharmaceutical Clinical Research as a Medical Reviewer/Associate Director that will allow me to utilize my clinical, analytical, and deductive skills in a research and clinical environment. Through my international studies and domestic research, I have gained a unique perspective in the clinical research area.

SUMMARY OF QUALIFICATIONS

• 3 years of Excellent Clinical Research experience (Phase II & III) in monitoring, data collection/data entry in Clinical Trial Research in Hematology/Oncology, Interventional Cardiology closely working with Principle Investigators, and Drug Safety/Pharmacovigilance in the Pharmaceutical Industry.

• Extensive one-on-one clinical skills in patient evaluation/treatment for various conditions. Fully engaged patients to obtain clinical data and gain deeper knowledge of associated medical and scientific issues.

• Experience in obtaining, reviewing, and processing regulatory and administrative documents from investigator sites.

• Knowledge of GCPs, ICH guidelines, EDC, CRF and IVRs.

• Plan, Initiate and execute Phase III and IV Clinical Trials Studies according to specific timelines.

• IRB and Informed Consent Submission.

• Experience with Individual patient follow-up reports and Death reports.

• Experience with IRB submissions, Informed Consents, and FDA regulations.

• Experience in regulatory processing of Research Clinical Trials.

• Experience with enrolling patients, informed consents, and reporting adverse effects for clinical trial research, and monitoring patients throughout various studies involved.

• Analyze Patient Medical information and AE/SAE, SUSAR/ASE (Analysis of Similar Events Summary) reports, Signal Detection and FDA submissions, vital signs, ECG and various laboratory data.

• Experience with Electronic Medical Records and Safety Database.

• Experience in conducting QC and final medical review of Individual Safety Case Reports (ICSRs) for Adverse Events and Serious Adverse Events after reviewing of source documents, write narratives and also experience with coding.

• Excellent understanding of medical diseases and treatments (clinical).

• Worked independently as well as collaboratively with physicians, nurses, patients and patient families throughout my career with strong knowledge of medical terminology.

• Excellent interpersonal, organizational, analytical, team skills, and computer skills, with extensive attention to detail, ability to multi-task and an overall team player.

• Willingness to travel.

• Ability to work in strenuous situations and produce effective results with no supervision.

EDUCATION

Destiny University School of Medicine & Health Sciences, Saint Lucia, West Indies

Doctor of Medicine 2010

• Clinical clerkships with attending physicians/principal investigators on clinical research studies in therapeutic areas including Hematology/Oncology, and Interventional Cardiology.

• Completed rotations in General Surgery, Obstetrics & Gynecology, Neurology, Family Medicine, Internal Medicine, Pediatrics, Psychiatry, Pulmonology, and Urology.

Lake Forest College, Lake Forest, Illinois

Bachelor of Sciences – Environmental Science 1999

EXPERIENCE

Takeda Pharmaceuticals, Deerfield, IL October 2011 – May 11, 2012

Drug Safety/Pharmacovigilance Specialist

• Conduct global medical review of Individual Case Safety Reports (ICSR) for Adverse Events and Serious Adverse Event’s (SAE), including coding, perform internal causality assessments and determine regulatory reportability of clinical trial cases for investigational new drugs on numerous clinical trials as well as SUSAR reports.

• Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment.

• Ensure complete and timely reporting of medical cases associated with various clinical trial studies to regulatory authorities globally.

• Assist with managing multiple clinical trial studies associated with Type II Diabetes Mellitus.

• Provide Quality Control and Quality Assurance of Adverse Event reporting to ensure consistency of work practices and SOPs.

• Assist in safety analysis of initial and follow-up serious and non-serious adverse events and vital sign, ECG and laboratory data.

• Assist in medical review of paper and electronic case report forms (eCRFs) including query issuance and resolution.

• Assist in training individuals in ICSRs, SUSAR reports/submissions and ARISg safety database according to Takeda standards.

• Triage/QC review and follow-up assessment of safety case reports and conduct final Medical Review of ICSRs, determine seriousness and assess causality.

• Assist with narrative writing for cases associated with multiple studies.

• Assist with the Adjudication process for specific studies.

• Extensive experience in signal detection, writing Analysis of Similar Events Summary (ASE) associated with SUSAR cases.

• Work closely with various MDs in processing SUSAR/ASE reports and FDA submissions.

• Ensure that tasks are performed in the most efficiently manner possible upholding quality, accuracy, and safety standards in accordance with cost effectiveness goals.

• Ensure complete and timely review and causality assessment of medical cases to regulatory authorities in the United States (FDA), Canada, Europe, and Japan.

• Liaise with CROs and other relevant functional areas within TGRD to obtain safety data and to provide safety input.

• Liaise with Healthcare professionals and consumers for follow-up of case reports.

• Work closely with Takeda’s Medical Reviewers in European and Japanese markets in evaluating the safety profile of compounds to ensure Takeda’s commitment to the promotion of Global Health.

• Utilize data mining strategies and MeDRA to effectively provide adequate Pharmacovigilance.

University of Illinois Medical Center & Jesse Brown VA Medical Center, Chicago, IL April 2011 – October 2011

Clinical Research Coordinator – Department of Medicine – Section of Cardiology

• Managed Clinical Trial Studies for Interventional and Non-Interventional Cardiology at UIC and Jesse Brown VA Medical Center.

• Initiated and maintained working relationships with Pharmaceutical Study Sponsors, CROs, Physicians, Patients and the Hospital) in order to attract and facilitate clinical trials.

• Conducted all study related procedures for Phase II and III clinical trials in both Pharmaceutical and Medical Device arenas.

• Aided in Subject recruitment, Patient Care.

• Responsible for all Internal Site Medical Review such as Case Report Forms (CRFs), Adverse Event (AE)/Serious Adverse Event (SAE) monitoring and timely reporting to the IRB and Sponsor as necessary.

• Responsible for Processing of Blood samples for various clinical trial studies.

• Aided in the implementation and monitoring of complex clinical trials, preparation of Institutional Review Board (IRB) Submissions, Food and Drug Administration (FDA) Regulatory Submissions, and ensured that Good Clinical Practices (GCP) was followed.

• Aided in the Informed Consent process and ensured compliance with the protocol.

• Aided in the design, revision, and submission of Source Documents and Informed Consents which provided adequate efficacy and safety information for clinical trials according to UIC IRB protocol.

• Responsible for all Internal Site Medical Review before being submitted to Pharmaceutical Company.

• Aided in managing/organizing CME accredited Transradial Courses with Interventional Cardiologists at UIC & Jesse Brown VA Medical Center.

• Established and maintained relationships with various organizations (i.e, St. Jude Medical Center, Terumo, etc. for CME accrediated courses at UIC and Jesse Brown VA Medical Center.

• Organized/managed Budget/Grants with various organizations (i.e, St. Jude Medical Center, Terumo, etc) for CME accredited courses at UIC and Jessse Brown VA center.

• Maintained professional knowledge by actively participating in continuing medical education activities in the forms of online courses (Heart.org).

• Aided in a Post-Approval study of the TAXUS Liberte Paclitaxel-Eluting Coronary Stent System.

• Aided in a “Randomized controlled study to evaluate the safety and effectiveness of the Tryton Side Branch Stent used in conjunction with a Drug-Eluting Stent compared to Side Branch Balloon Angioplasty in conjunction with a Drug-Eluting Stent in the treatment of de novo Bifurcation Lesions involving the Main Branch and Side Branch within the Native Coronary Circulation.”

• Aided in double blinded clinical trial measuring the effectiveness of Dual Antiplatelet Therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions.

• Aided in clinical trial comparing cangrelor to clopidogrel standard of care therapy in subjects who required percutaneous coronary intervention.

RSA Medical, Naperville, IL July 2010 – December 2010

Medical Case Manager

• Conducted medical interviews with applicants/patients for health insurance companies and obtained patient medical histories.

• Analyzed and communicated patient applications to insurance underwriters for approval.

• Followed HIPAA regulations regarding patient medical records and confidentiality.

• Gained experience in EMRs (Electronic Medical Records) and customer service.

• Worked with a variety of patients/applicants, nurses, and physicians individually and collaboratively.

• Worked together with a large number of employees which maintained a strong knowledge base.

• Educated in the latest advances of drugs, medical conditions and their associated treatments, and medical terminology.

Hematology Oncology Consultants, Ltd., Naperville, IL September 2009 – June 2010

Volunteer Clinical Research Assistant (Oncology Clinical Trial Coordinator (Phase II & III))

• Managed the life cycle of a clinical trial encompassing patient enrollment, informed consent forms, CRFs, and reporting diagnosis vs. drug adverse effects.

• Conducted QOPI project data collection for clinical trials & intergroup studies.

• Conducted clinical trial treatments with subjects and drug accountability.

• Determined study with associated drug treatments for testing the following treatments: Breast, Colon, Colorectal, & Lung Cancer.

• Screened, enrolled, and followed patients along with the coordinator ensuring protocol compliance and close monitoring during their treatments.

• Communicated regularly with the Principal Investigator regarding studies/patients.

• Maintained patient follow-up forms and Death Reports.

• Resolved queries of CRF data with study site personnel.

• Reviewed protocols and also tables and listings generated from study data.

• Strong use and experience with ICH guidelines and GCPs.

MJ Medical Group, Chicago, IL April 2005 – September 2007

Assistant to the Attending Family Physician

• Analyzed patient history, patient medical/drug assessments

• Performed patient physical examinations.

• Recommended treatment plans for a variety of diagnoses.

• Presented all cases to the attending physician.

• Experience in Electronic Medical Records (EMR) - (i.e. Medinotes).

• Working Clientele: Weiss Memorial Hospital, Lake Shore Medical, and MJ Medical Group.

Rush University Medical Hospital, Chicago, IL January 2006 – March 2006

Volunteer Research Assistant

• Involved in research projects on Left Ventricular Assistant Device (LVAD) implantation and efficacy.

• Observed procedures including MI induction.

• Assisted surgeons in O.R with LVAD placement.

• Assisted in subject observation and retrieval of research studies.

Abbott Laboratories, Abbott Park, IL August 1999 – January 2001

Quality Assurance Specialist

• Verified and approved tested products according to Abbott standards and requirements.

• Communicated with several departments within Abbott regarding Abbott products.

• Analyzed, scanned, retrieved, and stored medical electronic records.

Lake Forest College, Lake Forest, IL September 1996 – May 1999

Student Supervisor

• Worked as part-time student supervisor in circulation department in the Lake Forest college main library and Johnson Science Library.

• Managed the circulation area of the library and the student staff.

• Attended to students and professors as needed.

VOLUNTEER WORK

• Saint Theresa’s Medical Center, Waukegan, IL – 1993

• Victory Memorial Hospital, Waukegan, IL – 1993-1995

• Rush University Medical Center, Chicago, IL – January 2006 – March 2006

• Hematology Oncology Consultants, Ltd., Naperville, IL – September 2009 – June 2010

CLINICAL TRIALS

PROMISE: “Prospective Multi-center Imaging Study for Evaluation of Chest Pain”

To determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). “

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

ARO: Duke Clinical Research Institute

CHAMPION PHOENIX: “A clinical trial comparing cangrelor to clopidogrel standard of care therapy in subjects who require percutaneous coronary intervention. (Protocol TMC-CAN-10-01). (Cangrelor versus standard therapy to achieve optimal management of platelet inhibition).”

Sponsor: The Medicines Company

DAPT Study: “A prospective, Multi-center, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of Dual Antiplatelet Therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions.”

Sponsor: Harvard Clinical Research Institute (HCRI)

TAXUS Liberte Post-Approval Study: “A U.S. Post-Approval study of the TAXUS Liberte Paclitaxel-Eluting Coronary Stent System.”

Sponsor: Boston Scientific Corporation

Co-Sponsors: Eli Lilly & Company, Daiichi Sankyo, Inc.

TRYTON Study: “A prospective, Single-Blind, Randomized controlled study to evaluate the safety and effectiveness of the Tryton Side Branch Stent used in conjunction with a Drug-Eluting Stent compared to Side Branch Balloon Angioplasty in conjunction with a Drug-Eluting Stent in the treatment of de novo Bifurcation Lesions involving the Main Branch and Side Branch within the Native Coronary Circulation.”

Sponsors: Tryton Medical, Inc.

CRO: Paragon Biomedical, Inc.

TAO (Treatment of Acute Coronary Syndrome with Otamixaban): “A randomized, double-blind, triple-dummy trial to compare the efficacy of Otamixaban with Unfractionated Heparin + Eptifibatide in patients with

Unstable Angina/Non-ST segment elevation Myocardial Infraction scheduled to undergo an early invasive strategy.” (Protocol EFC6204-TAO)

Sponsor: Sanofi-Aventis, Inc., U.S.

USpella (Impella 2.5)

Left Ventricular Assistant Device (LVAD) placement in Heart Failure – via Femoral access

Sponsor: Abiomed, Inc.

CHART (Congestive Heart Failure Adherence Redesign Trial): “A Multi-level behavioral randomized efficacy trial featuring low-income patients hospitalized for Acute Exacerbation of Heart Failure and their Primary Care Doctors to reduce hospitalizations.”

Sponsor: National Institute of Health (NIH) Centers for Population Health and Health Disparities (CPHHD)

PCN (Peripartum Cardiomyopathy Network) - Immune Activation and Myocardial Recovery in Peripartum Cardiomyopathy):

To study the relationships between hormonal and cellular events of pregnancy, systemic immune activation, myocardial inflammation, the development of PeriPartum Cardiomyopathy and its resolution and to determine

the degree of immune activation in PPCM and the relationship of autoimmunity to left ventricular dysfunction (using Echocardiography) and time course of myocardial recovery.

Sponsor: National Institute of Health (NIH)

COMPUTER SKILLS

Software: WordPerfect, Microsoft Office, Microsoft Word, Microsoft Outlook, Microsoft Excel, Microsoft PowerPoint.

Online Database Management: Medinotes (EMRs), IVRS/IXRS, eCRFs (MediData Rave, Merge EDC, InForm), and Query analysis.

Drug Safety Database: ARISg (TGeae) v. 14

MedDRA v.14.1

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