Medical Affairs Research Operations Intern Executive Director, Sr. Director, Senior Medical Monitor, Project Manager Remote Study Specialist, Clinical Team Manager, Study Coordinator, Project Assistant, Executive Assistant, Strategic Feasibility Specialist Resume Example
MEDICAL AFFAIRS RESEARCH OPERATIONS INTERN EXECUTIVE DIRECTOR SR DIRECTOR SENIOR MEDICAL MONITOR
Driven and compassionate Clinical Research professional with 2 years' combined experience in a fast-paced CRO internship and UNCW's Clinical Research Bachelors of Science program.
Windows 95-2003, Vista, Windows 7, Mac OS X
Microsoft Office Suite; Word, Excel, PowerPoint, Outlook
Internet Explorer, Mozilla Firefox, Google Chrome, Safari
REMS Amalga Platform
PPD's Mastermind, RegView, Content Server
Evidera Budget Analysis Reporting
Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without XXX
Randomized, Double-Blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of XXX versus XXX for Women in Spontaneous Preterm Labor.
Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in XXX Treatment Studies.
Observational study: Pregnancy Registry that is a global, multi-center, prospective cohort study to evaluate pregnant women's exposure to XXX a Systemic Lupus Erythematosus treatment and its effect on birth defects and other pregnancy outcomes.
XXX Pregnancy Registry: an Observational Study of the Safety of XXX Exposure in Pregnant Women and Their Offspring.
XXX Pregnancy Registry: a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following exposure to XXX during pregnancy.
Opioid Risk Evaluation and Mitigation Strategy (REMS) Program.
COPD Inhalation Powder Risk Evaluation and Mitigation Strategy (REMS) Program: Safety notice program for Acute Bronchospasm associated with patients taking XXX.
09/2016 to Current
Medical Affairs Research Operations Intern Executive Director, Sr. Director, Senior Medical Monitor, Project Manager Remote Study Specialist, Clinical Team Manager, Study Coordinator, Project Assistant, Executive Assistant, Strategic Feasibility SpecialistPPD, Inc CRA － Wilmington, NC
Pregnancy Registries and REMS (Risk Evaluation and Mitigation Strategies) Department.
Manage the development of department SOPs and WPDs including coordinating working groups, scheduling and facilitating meetings, setting and managing timelines, compose meeting minutes, assisting in writing and editing, as well as managing the submission process to the PPD Procedural Documents Committee.
Lead coordinator for Pregnancy Registries research abstract presentation for the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2017 conference.
Managing tasks include; coordinating meetings with co-authors, abstract preparation, collecting data for abstracts and assisting with analyzation of research trends.
Engineers various work projects for multiple MARO departments:.
Develop training and demo versions of REMS Amalga Platform server to be used by current and potential sponsors.
Cultivate a strategic patient recruitment plan for a pregnancy registry study.
Aid in audit and comprehensive reviews of study protocols, monitoring plans, patient consent forms and monthly CIOMS reports of numerous studies.
Analyze safety reporting processes and pharmacovigilance surveillance for multiple pregnancy registry studies through Spot Fire, a safety data management program.
Collect prescriber contact information for a REMS program yearly survey.
Collect and report bi-weekly project progress assessments (% complete estimates) for Evidera's revenue recognition report summaries.
Organize and files key study documents in the Trial Master file (TMF) and Content Server.
Attended educational seminars on various PPD departments: Evidera, Pharmacovigilance, Data Management, Strategic Proposal Development, Government Affairs, Strategic Clinical Development, Acurian, SIA, and Strategic Feasibility.
Develop collaborative relationships with fellow team members and across PPD departments (i.e.
Evidera, Clinical Development, Regulatory, SIA, GCS, PVG/MA, Global Quality and Compliance).
Shadowing of various positions to understand job roles (i.e.
01/2016 to 12/2016
Assistant ManagerPaw Beach Pet Resort － Wilmington, NC
Managed facility operations on weekends and coordinated daily procedures with other staff members.
Responsible for medicating, feeding, caring and attending to lodging pets.
Education and Training
Bachelor of Science: Clinical ResearchUniversity of North Carolina WilmingtonClinical Research
Basics of Clinical Research, Medical Terminology & Clinical Endpoints, Bioethics, Fundamentals of Product Development, Scientific Literature Seminar, Scientific Writing, and Introduction to Pharmacotherapeutics, Regulatory Affairs, Managing and Monitoring Clinical Trials, Data Management, Advanced Scientific Writing, and Bioanalytics.University of North Carolina3.89
BS: Animal ScienceNorth Carolina State UniversityAnimal Science
PPD Clinical Foundations Training (AMER- Remote Site Monitor)
*Medidata Rave Certified Professional- Certified Principal Investigator
*PPD Wilmington Toastmasters International Best Speaker Award
*NIDA Clinical Trials Network GCP Certificate
*CDER World of Compliance FDA Training Certificate
Covington DL, Buus R, Blum C. Reference Groups Used in Pregnancy Exposure Registries: Challenges and Opportunities. Health Care Use & Policy Studies (HP) 2017; ## (No #):###.
Budget Analysis, bi, Clinical Development, Clinical Research, Clinical Trials, Content, Data Management, editing, forms, GCP, Government, Internet Explorer, MA, Mac OS, Managing, Medical Terminology, meetings, Excel, Microsoft Office Suite, Outlook, PowerPoint, Windows 7, Windows 95, Word, Network, processes, Product Development, progress, Proposal Development, protocols, Speaker, Quality, recruitment, Regulatory Affairs, reporting, Research, revenue recognition, safety, scheduling, Scientific, Scientific Writing, seminars, Strategic, Vista
Medical Affairs Research Operations Intern Executive Director, Sr. Director, Senior Medical Monitor, Project Manager Remote Study Specialist, Clinical Team Manager, Study Coordinator, Project Assistant, Executive Assistant, Strategic Feasibility Specialist
Bachelor of Science : Clinical Research Basics of Clinical Research, Medical Terminology & Clinical Endpoints, Bioethics, Fundamentals of Product Development, Scientific Literature Seminar, Scientific Writing, and Introduction to Pharmacotherapeutics, Regulatory Affairs, Managing and Monitoring Clinical Trials, Data Management, Advanced Scientific Writing, and Bioanalytics. BS : Animal Science
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