Clinical Research Data Entry
Resume:
Diane Chase
Pharmacovigilance Specialist
PROFESSIONAL SUMMARY
With over fifteen (15) years clinical research experience, 11 years in Pharmacovigilance and four (4) years as a Clinical Research Coordinator in phase I-IV clinical trials. Therapeutic areas of experience include: Immunology (Seasonal Allergic Rhinitis, HSV Vaccine), Cardiology (HTN, Atrial Fibrillation, pediatric cardiac device), CNS (Multiple Sclerosis), Endocrinology (Type 1, II Diabetes), Gastroenterology (Heartburn, Crohn’s Disease, Ulcerative Colitis, Irritable Bowel Syndrome, Duodenal Ulcer), Musculoskeletal (Osteoarthritis), Oncology (Ovarian, Multiple Myeloma, Breast, Colorectal, Solid Tumor, Lymphoma, Pancreatic, Prostatic), Infectious Disease (Septicemia, Acute Sinus Infection, CMV infection Post-Transplant), Genitourinary (Urinary Incontinence, Benign Prostatic hyperplasia, Focal Segmental Glomerulosclerosis), Nutritional, Medical Device (Liver Transplant) and Respiratory (Asthma).
PROFESSIONAL EXPERIENCE
JUL/2022-AUG/2023 Proxima CRO, Houston TX
Drug Safety Associate
Medical Devices, Oncology drug and infectious disease trials, Responsibility included triage of ISCRs, narrative writing and query generation.
OCT/2021-MAY/2022 Synteract, Morrisville, NC
Senior Pharmacovigilance Specialist
Responsibilities included SAE case management which included receipt of adverse event data, initial case disposition, confirmation of case disposition with Medical Monitor (MM), data entry, source document data extraction, draft narrative development, follow up SAE case management and reporting according to regulatory requirements.
OCT/2018-JUL/2021 Clinipace CRO, Morrisville, NC
Lead Pharmacovigilance Specialist
Responsibilities included SAE case management which included receipt of adverse event data, initial case disposition, confirmation of case disposition with Medical Monitor (MM), data entry, source document data extraction, draft narrative development, follow up SAE case management and reporting according to regulatory requirements.
FEB/2012-JUN2018 Pharmaceutical Product t Development (PPD) Morrisville, NC
Safety Specialist
Conducted pharmacovigilance tasks for multi-le clinical trial simultaneously. Responsibilities included ICSR triage, narrative generation with source document review, query generation, data entry, regulatory reporting (MedWatch and CIOMS), and sponsor weekly interfacing.
FEB2011-FEB2012 UNC Chapel Hill, NC
Clinical Research Nurse (Floor)
Executed Phase I-IV clinical trials in a clinical setting. Tasks included starting IVs, blood draws, vital signs, sample collection and data entry.
EDUCATION, LICENSURE & CERTIFICATION
Windham Regional Technical Vocational School LPN diploma (Licensed in NC from 19952015)
Department of Health and Human Services HIG Good Clinical Practice (GCP)certification 01May2024-current
Medical coding Certification Online 07JUN2024-current
TECHNICAL SKILLS
Safety/clinical databases and other systems: Phase Forward-INFORM, Medidata RAVE, AERS, Science 37, Clintrace, Oracle RDC, ARIS-G, Argus, and Medrio.
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