Summary
Overview
Work History
Education
Skills
Curriculumvitae
Previous Experience
Affiliations
References
Timeline
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ASHLEY MCFADDEN

ASHLEY MCFADDEN

Wayne,PA

Summary

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.

Overview

8
8
years of professional experience

Work History

Study Coordinator

Protex-RSI Technology Group
01.2022 - Current
  • Use of Protex for ART procedures
  • Reviewed patient medical records for completeness and accuracy according to protocol specifications.
  • Maintained close communication with project teams including investigators, CRAs, vendors and external partners regarding study milestones and timelines.
  • Coordinated research site visits for sponsors and monitors by arranging travel logistics, scheduling meetings, compiling documentation for review sessions.
  • Responded promptly to inquiries from investigational sites pertaining to study-specific issues or questions.

Study Coordinator

Overture Life, Inc.
01.2021 - Current
  • Comparison of metabolomics embryo selection with current standard of care embryo selection methods

Study Coordinator

Femasys Inc.
01.2021 - Current
  • Prospective Multi- Center Localized Directional Insemination Trial for Artificial Insemination

Study Coordinator

Granata Bio
01.2021 - Current
  • Subcutaneous progesterone in frozen-thawed single euploid blastocyst transfer

Clinical Research Coordinator

Main Line Fertility
Bryn Mawr, Pa
09.2020 - Current
  • 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

Study Coordinator

Research & Development Institute
01.2021 - 01.2022
  • Minimal Risk Blood Collection Protocol for a Biorepository to Support Future Development of Women's Health and Fertility Assays

Study Coordinator

Lia Diagnostics
01.2020 - 01.2021
  • Early Pregnancy Test Usability Study

Study Coordinator

Lia Diagnostics
01.2020 - 01.2021
  • Early Pregnancy Test Detection Study

IVF Monitoring Clinical Assistant

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

Education

Master of Science - Education

Cabrini University
Wayne, PA
06-2010

Bachelor of Science - Education

Saint Josephs University
Philadelphia, PA
06-2008

Skills

  • Documentation Management
  • Clinical Research
  • Protocol development
  • Study design
  • Data Collection
  • Good clinical practice
  • Trial oversight
  • Records Maintenance
  • Schedule Coordination
  • Medication Dispensing
  • Case report management
  • Documentation requirements

Curriculumvitae

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

Previous Experience

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

Affiliations

  • Division 1 Lacrosse Player
  • Founded Girl's Lacrosse Program at KIPP West Philadelphia Charter School

References

References available upon request.

Timeline

Study Coordinator

Protex-RSI Technology Group
01.2022 - Current

Study Coordinator

Overture Life, Inc.
01.2021 - Current

Study Coordinator

Femasys Inc.
01.2021 - Current

Study Coordinator

Granata Bio
01.2021 - Current

Study Coordinator

Research & Development Institute
01.2021 - 01.2022

Clinical Research Coordinator

Main Line Fertility
09.2020 - Current

Study Coordinator

Lia Diagnostics
01.2020 - 01.2021

Study Coordinator

Lia Diagnostics
01.2020 - 01.2021

IVF Monitoring Clinical Assistant

09.2016 - 08.2020

Master of Science - Education

Cabrini University

Bachelor of Science - Education

Saint Josephs University
ASHLEY MCFADDEN