Jean Edwards

Gurnee, IL *****

adyxgs@r.postjobfree.com

+1-407-***-****

Authorized to work in the US for any employer.

Work Experience

Clinical Research Coordinator II - Urology

UNC Lineberger Comprehensive Cancer Center - Chapel Hill, NC August 2019 to October 2022

• Review and consent subjects to Clinical Trials.

• Assess and Monitor subjects for adverse events and response to precool medication.

• Maintain all protocol required lab kits, order kit if necessary and prep kits for the lab to draw.

• Coordinate subject visits per protocol.

• Assess subject eligibility and review with investigator.

• Present and review Subject questionnaires.

• Present and review patient pill diaries.

• Cross train with other disease sites

• Provide protocol training to non-research departments.

• Collaborates with physicians and other healthcare staff to ensure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and act as appropriate.

• Present patient status at weekly POD meeting to investigators, regulatory, CRCs and data coordinators.

• Maintains compliance with all University of North Carolina policies and procedures. Project Manager

Vaco Staffing - Maitland, FL

September 2018 to August 2019

• Manages, coordinates, and monitors specific projects and tasks to build an effective CTMS infrastructure that supports Florida Hospital Research Institute's (FHRI's) goals of efficient clinical research study implementation, processes, finances, and reporting, all which further improve the experiences of participants on clinical trials.

• Optimizes CTMS application efficiency by working collaboratively with institutional partners to integrate with other clinical operating system such as the electronic medical record system. Oncology Abstractor

Flatiron Health - New York, NY

March 2016 to January 2019

• Review medical record for Oncology abstracting into a database for areas of Breast Cancer, Colorectal Cancer and Non-Small Cell Lung Cancer for a medical company with an annual revenue of $1.9b.

• Generate queries with understanding of QC/QA processes.

• Possess a high level of understanding of Patient Manager workings.

• Fluent in medical terminology and ensure HIPAA compliance.

• Chosen as a Spotlight Team Member as a specialty abstractor. Quality Assurance Specialist

Omega Research - Orlando, FL

January 2018 to August 2018

• Review monthly over 450 charts for FDA and regulatory adherence. Ensure that all chart ocumentation is clear and understandable.

• Collaborate with Clinical Coordinators for any patient concerns (blood pressure or any out of medical range metrics).

• Audit one study per month with emphasis on regulatory and patient safety resulting in 92% decrease of findings based on monitors and audit reports.

• Make sure that all protocol windows are met; developed CAPA's based on risk- based methodology. Clinical Research Coordinator II

Bioclinica - The Villages, FL

May 2016 to January 2017

• Oversaw the management and training of 20 employees.

• Coordinated multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).

• Managed clinical research trials in the areas of Alzheimer's Disease and Pain Management.

• Assessed over 100 patients for protocol eligibility and communicated findings to investigator/physician.

• Operated specialized equipment (EKG, Centrifuge, Automated Blood Pressure, Pulse oximeters, Infusion Pumps) as needed in assigned area.

• Assessed and monitored patient responses and adverse reactions; reported same to accountable sources.

Clinical Research Associate

GeNO, LLC - Cocoa, FL

May 2015 to May 2016

• Assisted in investigator study selection and start-up for an organization with an annual revenue of over

$1b.

• Created clinical project documents according to the protocol such as source documents forms

& guidelines, instructions on use, monitoring visit templates and reports with more accurate data collection.

• Identified site issues and coordinated corrective action plans based on need.

• Wrote Standard Operating Procedures based FDA regulations and ICH guidelines.

• Created and utilized Site Payment Database for accurate and timely study specific payments.

• Performed as the Team Leader for the implementation of new study databases including UAT, data entry and data transfer for interim.

Clinical Research Coordinator II

Orlando Health - Orlando, FL

November 2007 to March 2015

• Oversaw the management and training of 7 employees.

• Coordinated over 50 multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).

• Managed clinical research trials in the areas of oncology - primarily in Melanoma/Sarcoma, Hematology and GI in Phase I-IV studies.

• Lead Phase I CRC in multi-indications, including Altor801 and DC Vax.

• Assessed over 500 patients for protocol eligibility and communicated findings to investigator/physician.

• Operated specialized equipment (EKG, Centrifuge, Automated Blood Pressure, Pulse oximeters, Infusion Pumps) as needed in assigned area.

• Assessed and monitored patient responses and adverse reactions; reported same to accountable sources.

• Lead CRC in Melanoma/Sarcoma Section.

• Multi-computer program trainer and superuser (Sunrise, SharePoint, Access and eCRF).

• Provided protocol trainings needed to non-research employees in other departments.

• Maintains regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards.

• Maintains compliance with all Orlando Health policies and procedures.

• Collaborates with physicians and other healthcare staff to ensure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.

• Provides appropriate patient and family education.

• Assist in the preparation and submission of amendments to clinical trials protocols to the IRB. Education

License

Lively Technical Institute - Tallahassee, FL

1995 - 1996

Associate of Arts

Valencia College - Orlando, FL

1990 - 1993

Skills

• Skills

• Clinical Conductor

• Quality Assurance

• Microsoft Office Suite

• Source Document Development

• iMedidata / RAVE

• Good Clinical Practice GCP/ICH

• OneDrive / Google Drive

• Leadership

• Oracle

• Team Trainer

• Budgets

• Medical Records Review

• Policies and Procedures

• Clinical Research Phase I-IV Alzheimer's Disease, Depression

• Protocol Adherence

• Oncology

• Pain Management

• Clinical Trials

• FDA Regulations

• Microsoft SharePoint

• Microsoft Office

Certifications and Licenses

LPN

January 2002 to December 2023

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