Summary
Overview
Work History
Education
Skills
Therapeutic Experience
Certification
References
Timeline
Generic

Amy Reed

Jacksonville

Summary

Seasoned Senior Clinical Research Associate with background in managing and overseeing clinical trials. Expertise in clinical trial protocols and patient communication, with extensive experience across all phases of clinical studies (I-IV). Demonstrated leadership in monitoring clinical activities and ensuring compliance with regulatory standards. Proven ability to enhance processes and optimize workflow, contributing to high-quality research outcomes.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Senior Clinical Research Associate

IQVIA and its Affiliated Companies
03.2023 - Current
  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
  • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Clinical Research Associate

ICON plc
04.2021 - 03.2023
  • Perform site monitoring visits (initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.

Professional Relations Project Management Administrator

Johnson and Johnson Vision
12.2020 - 04.2021
  • Provides oversight and implementation of funding requests for the Professional Affairs group, which includes the preparation and processing of contracts and sponsorships.
  • Coordinates, develops, and provides analysis of projects and contracts/agreements with external vendors, contractors, and association leaders.
  • Provides technical administrative support and communication facilitation.
  • Constructs/creates/prepares communications and/or presentations.
  • Manages contracts and sponsorships, liaison for stakeholders in coordination of contract specifics, and identifies materials for sponsorship deliverables.

Clinical Research Coordinator

Cancer Specialists of North Florida
09.2019 - 12.2020
  • Responsible for ensuring study is compliance with local and federal laws and regulations.
  • Recruits and screens potential study participants and performs intake assessments.
  • Creates and/or maintains all documents and records related to the study.
  • Acts as a point of reference for study participants by answering questions and keeping them informed on the study progress.
  • Manages the inventory of equipment and supplies related to the study and orders more as needed.
  • Attends meetings, events and seminars in order to promote the study.
  • Collects specimens and inputs data and patient information into electronic systems.
  • Creates reports on each study, including notes on protocols, workload, data collection, and more.

Clinical Research Coordinator

Mayo Clinic Florida
11.2018 - 09.2019
  • Responsible for ensuring study is compliance with local and federal laws and regulations.
  • Recruits and screens potential study participants and performs intake assessments.
  • Creates and/or maintains all documents and records related to the study.
  • Acts as a point of reference for study participants by answering questions and keeping them informed on the study progress.
  • Manages the inventory of equipment and supplies related to the study and orders more as needed.
  • Attends meetings, events and seminars in order to promote the study.
  • Collects specimens and inputs data and patient information into electronic systems.
  • Creates reports on each study, including notes on protocols, workload, data collection, and more.

Certified Oncology Pharmacy Technician

Mayo Clinic Florida
09.2016 - 11.2018
  • Prepares chemotherapy infusions and clinical research investigational treatments (per IRB guidelines) by following clean room procedures per US 797.
  • Lead technician for the Quality and Safety Subcommittee to review reported errors within the Oncology outpatient clinic; worked to ensure measures were put into place to improve production and turnover times for patients, while following and maintaining safety protocols.

Certified Pharmacy Technician

Mayo Clinic Hospital
05.2011 - 09.2016
  • Performed operational duties, including support and sterile/non-sterile compounding.
  • Developed training materials and provided training/education to pharmacy and hospital staff.
  • Helped manage a Quality Improvement Project where new inventory management processes were developed, leading to nearly $1 million dollars saved annually on unused inventory.
  • Developed and managed the Clinical Technologies Technician role, which was responsible for collaborating with Pharmacy Informatics team and nursing staff to implement bedside barcode medication administration and streamline inventory in automated medication dispensing nursing stations.

Education

Bachelor of Science - Health Education

University of Florida
United States
08.2018

Skills

  • Site monitoring
  • Clinical trial management
  • Regulatory compliance
  • Patient recruitment strategies
  • Data integrity assessment
  • Project coordination
  • Electronic data capture systems
  • Trip reports
  • Therapeutic area expertise
  • ICH-gCP guidelines

Therapeutic Experience

  • Oncology: Malignant Tumor of Lung, Malignant Tumor of Prostate, Malignant Neoplasm of Liver, Malignant Tumor of Breast, Malignant Tumor of Colon, Malignant Tumor of Esophagus, Malignant Tumor of Ovary, Solid Tumor Configurations, Glioblastoma Multiforme, Hematologic Malignancy
  • Cardiovascular: Hypertensive disorder (Device Trials)
  • Hepatology: Nonalcoholic Steatohepatits
  • Metabolic disease

Certification

IQVIA GCP Certification Exam, 06/17/2025

References

References available upon request.

Timeline

Senior Clinical Research Associate

IQVIA and its Affiliated Companies
03.2023 - Current

Clinical Research Associate

ICON plc
04.2021 - 03.2023

Professional Relations Project Management Administrator

Johnson and Johnson Vision
12.2020 - 04.2021

Clinical Research Coordinator

Cancer Specialists of North Florida
09.2019 - 12.2020

Clinical Research Coordinator

Mayo Clinic Florida
11.2018 - 09.2019

Certified Oncology Pharmacy Technician

Mayo Clinic Florida
09.2016 - 11.2018

Certified Pharmacy Technician

Mayo Clinic Hospital
05.2011 - 09.2016

Bachelor of Science - Health Education

University of Florida

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