1. STEPHANIE MAJOR
1131 Princeton Avenue │ Philadelphia, PA 19111
(215)-237-7775 │majorstep@msn.com
S ENIOR CL INICAL RE SEARCH ASSOCIATE
A Senior Clinical Research Associate with extensive experience in the field over a span of 16 years across multiple
organizations and projects. Familiar with working remotely and performing tasks as a Blinded or Unblinded Monitor in a
timely and deadline driven environment in compliance with operating procedures for clinical studies. Able to identify,
investigate, and coordinate as well as provide leadership, training, and mentorship to fellow clinical research associates.
 High Quality Data Analysis
 Training, Supervision & Mentoring
 Compliance & Procedures
 Site Management
 Documentation & Submission
 Communication Skills
 Study Management
 Clinical Trial Development
 Budget Management
THE RAP EUT IC EX P E RI ENCE – PHAS E I , I I , I I I & IV
Infections (Skin Infections and Hepatitis B Virus), Metabolic (Weight Loss), Endocrinology (Diabetes Mellitus Type I & II),
Gastrointestinal (Dyspepsia, Irritable Bowel Syndrome and Constipation (Pediatric and Adults), Cardiovascular
(Hypertension, Left Ventricular Hypertrophy, Hypertriglyceridemia, & ApoC-III), Women's Health (Hormone
Replacement Therapy, Female Sexual Arousal Disorder, and Menorraghia), Pulmonary/Respiratory (Cystic Fibrosis,
Allergy/Asthma, Upper Respiratory Infection, COPD, & Pulmonary Hypertension), Hematology (Hepatitis B Virus),
Rheumatology (Pain Management: Osteoarthritis and Arthritis), Dermatology (Onychymycosis & Injection Site Reaction),
Ophthalmology (Diabetic Retinopathy & Wet Age-Related Macular Degeneration), Sedation, CNS ( Bipolar Disorder,
Schizophrenia, Fragile X Syndrome, & Autism), Oncology (Triple Negative Breast Cancer, Ovarian Cancer, Lymphoma &
Leukemia - CLL), Orphan Drug, Other (Transthyretin and Thromboembolic), Factor XI and Wound Care (Venus Ulcers)
COMPUT ER EX P E RI ENC E & TRAINING
 Eight years of EDC experience: Omnnicomm (TrialMaster), Inform, Data Fax, Clinphone, eResearch Technology
(Expert Data Capture), Medidata, BioClinica v5.1 & 5.2, Oracle, Data Labs (Perceptive) and other company specific
EDC systems
 Applications: Microsoft Office Suite, CTMS, Smart Pen System
 Training: RECIST v1.1
CURR ENT P ROF E S S IONAL EX P ER I ENCE
-SUCAMPO PHARMACEUTICALS
Senior Clinical Research Associate Consultant (2012 - Present)
-ISIS PHARMACEUTICAL INC.
Senior Clinical Research Associate Consultant & Pharmacy Monitor Consultant (2010 - Present)
 Prepare and conduct all site visits encompassing qualification, initiation, risk-based and co-monitoring, blinded
and unblinded monitor, motivational, audit support, and termination visits in compliance with FDA regulations,
ICH/GCP guidelines, and company SOPs.
 Identify centers for proposed studies and conduct feasibility assessments in collaboration with the project team.
 Organize and develop investigator files and relevant documentation ahead of the release of clinical supplies.
 Manage all study-related communication, assist in the writing and review process, and provide clinical monitoring.
 Track patient recruitment and liaise with project manager and Lead CRA to highlight study risks and opportunities.
 Collaborate with local and central laboratories as well as vendors to ensure protocol compliance.
 Update investigators financial file and compile payment requests in addition to developing clinical documents.
 Facilitate the preparation of documentation submissions as defined by local requirements and amendments.
 Analyze data flow and data query processing with data management team refining process improvements.
 Action status reports and interim safety reports in conjunction with project manager per country requirements.
 Distribute and track clinical trial supplies and meet all stated project deadlines and budget constraints.
 Assist in financial tracking in accordance with investigator, hospital, and pharmacy agreement terms.
 Foster and maintain third party relationships while reviewing and evaluating quality assurance of services.

2. STEPHANIE MAJOR Resume, Page 2
P REVIOUS P ROF E S S IONAL EX P ER I ENCE
 SEASIDE THERAPEUTICS – Senior Clinical Research Associate Consultant (2012 – 2013)
 PRA INTERNATIONAL – Senior Clinical Research Associate Consultant (2010)
 REGENERON PHARMACEUTICALS, INC. – Senior Clinical Research Associate Consultant (2010)
 MORPHOTEK, INC. – Senior Clinical Research Associate Consultant (2009 – 2010)
 RESEARCH DYNAMICS GROUP – Senior Clinical Research Associate Consultant (2009)
 ICON DEVELOPMENT SOLUTIONS – Senior Clinical Research Associate Consultant (2008 – 2009)
 INSPIRE PHARMACEUTICAL – Senior Clinical Research Associate Consultant (2008)
 TKL RESEARCH, INC. – Senior Clinical Research Associate Consultant (2007)
 LBR REGULATORY & CLINICAL CONSULTING SERVICE – Senior Clinical Research Associate Consultant
(2006 – 2007)
 GLAXOSMITHKLINE – Senior Clinical Research Associate Consultant (2004 – 2006)
 PPD – Clinical Research Associate Consultant (2004 – 2005)
 XYLOS CORPORATION – Clinical Research Associate Consultant (2003 – 2004)
 NOVARTIS PHARMACEUTICALS – Clinical Research Associate Consultant (2001 – 2003)
 ELI LILLY PHARMACEUTICAL – Clinical Research Associate (2000 – 2001)
 QUINTILES, INC. – Regional Clinical Research Associate (1998 – 2000)
 PENN CENTER FOR REHABILITATION & CARE – Social Service Director (1996 – 1998)
 NEW RALSTON HOUSE – Admissions Coordinator (1995 – 1996)
EDUCAT ION
Bachelor of Science: Psychology, Philadelphia College of Textiles & Science (1995)