Dedicated and adaptable professional with a proactive attitude and the ability to learn quickly. Strong work ethic and effective communication skills. Eager to contribute to a dynamic team and support organizational goals.
ASHLEY MCFADDEN, B.S., M.Ed., Clinical Research Coordinator, 08/2010, Masters of Education, Cabrini University, Radnor, PA, 05/2009, Bachelors Of Science of Education, St. Joseph's University, Philadelphia, PA, Main Line Fertility, Bryn Mawr, PA, Clinical Research Coordinator, Negotiating clinical trial budgets and contracts, Implementing the informed consent process with potential subjects, Generating and implementing the use of standardized Source Documents, Study Memos, and Drug Accountability Forms, Generating and submitting Annual Review/Close -Out Reports and Serious Adverse Events to IRBs, Preparing and submitting Essential Documents to Sponsors and IRBS, Maintaining Regulatory Documents for all clinical trials, Training clinical site staff in the proper execution of the clinical trial procedures, Completing the day-to-day operational activities associated with managing the clinical trials according to Sponsor Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP), Managing all CRF documentation including ECRF, Recruitment of trial subjects, Design and implementation of IIT (Investigator Initiated Trials), Recruitment of sponsors for clinical trials, Use of Protex for ART procedures, 2022, Present, Study Coordinator, Protex-RSI Technology Group, Minimal Risk Blood Collection Protocol for a Biorepository to Support Future Development of Women's Health and Fertility Assays, 2021, 2022, Study Coordinator, Research & Development Institute, Comparison of metabolomics embryo selection with current standard of care embryo selection methods, 2021, Present, Study Coordinator, Overture Life, Inc., Prospective Multi- Center Localized Directional Insemination Trial for Artificial Insemination, 2021, Present, Study Coordinator, Femasys Inc., Subcutaneous progesterone in frozen-thawed single euploid blastocyst transfer, 2021, Present, Study Coordinator, Granata Bio, Early Pregnancy Test Usability Study, 2020, 2021, Study Coordinator, Lia Diagnostics, Early Pregnancy Test Detection Study, 2020, 2021, Study Coordinator, Lia Diagnostics, 09/2016, 08/2020, Educated Patients on Medication Protocol and IVF Care Plan, Consented Patients, Met with pharmaceutical reps to learn advancements on IVF medications, Ordered Medications, Verified Insurance, Data Management, Managing data in Excel and SARTCORS, Tracking pregnancy outcomes, 12/2019, Present, Cabrini University, Master of Education, The effects of ADHD student inclusion in the classroom on math and reading proficiency parameters., Good Clinical Practice Certificate, Coordinating Clinical Research, 3, 09/2020, WIRB- Copernicus Group (WCG), Princeton, NJ
Main Line Fertility, Bryn Mawr, PA, IVF Monitoring Clinical Assistant, 09/2016, 08/2020, Instructed patients on injection medications, Assisted doctors and nurses with daily activities, Managed controlled ovarian stimulation and frozen embryo transfer cycles., Coordinated patient cycles in regard to insurance, medications, timing, and protocol