Work Preference
Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic
Open To Work

Tracy Williams Reed

Red Oak,TX

Work Preference

Job Search Status

Open to work
Desired start date: Immediately

Desired Job Title

Central Study Coordinator/Central Clinical ServicesOperations Manager/Clinical Research CoordinatorClinical Trial Document ManagerClinical Trial AssociateClinical Site Manager Support

Work Type

Full Time

Location Preference

RemoteHybridOn-Site
Location: Red Oak, TX, USDallas, TXFort Worth, TX
Open to relocation: Yes

Salary Range

$75000/yr - $200000/yr

Important To Me

Work-life balanceCareer advancementCompany CulturePersonal development programsHealthcare benefits401k matchWork from home optionPaid time offPaid sick leaveFlexible work hours

Summary

My objective is to establish a productive working relationship with a prosperous company and aspire to be an asset.

Overview

30
30
years of professional experience
1
1
Certification

Work History

Central Study Coordinator/Central Clinical Services

Care Access Research
2022.05 - 2026.03
  • Site and CRA support-EDC query resolution, enrollment logs, source upload to eTMF
  • Liaison between site staff and patient communications and updates
  • Schedule and complete virtual pt. visits and assessments, eConsent, MRI scheduling, pt. stipend and reimbursements
  • Organize weekly meetings with site staff and PI to review and/or to update any issue(s) pertaining to patient care, source, protocol workflow and resolutions.
  • Coordinate weekly meetings with Research Assistants
  • Coordinated study participant recruitment and retention efforts to enhance study enrollment.

Operations Manager/Clinical Research Coordinator

Ventavia Research Group
2021.04 - 2022.05
  • Manage office operations for 2 research sites- staff of 5
  • Site supplies, weekly enrollment goals, training and staff reviews, workflow assessments
  • Conduct study visit procedures, Informed consent process, drug accountability
  • Phlebotomy, lab specimen processing, HAZMAT shipping, CRF documentation and maintenance, adverse event/SAE, and query resolution.
  • Conduct PI weekly meetings for overall site assessment

Clinical Trial Document Manager

Greenlight Clinical Trials
2019.10 - 2021.04
  • Provide administrative support to Medical Leads and CRA’s
  • Maintain eTMF and archives.
  • Print study documents for Regulatory Binder and prepare site shipment-updated documents, SIV and Investigator Meetings
  • Maintain IP inventory, site supply maintenance, and weekly enrollment logs
  • Review feasibility questionnaires and vet potential PI’s for new research sites

Clinical Trial Associate

Smith & Nephew Inc.
2017.05 - 2019.10
  • Provide Clinical support to Global Site Management and CRA’s
  • Support and input documents to be archived
  • Provide support to sites- supply requests, enrollment, and product inventory
  • Support Financial/Contractual planning, study budgets, invoice payments and Sunshine Act report maintenance
  • Maintain accurate and complete financial record for global clinical studies
  • Essential document management
  • ETMF administrative support
  • Annual needs assessment process and SWAT entries and modifications
  • Vendor management, indirect procurement and point of contact for third party compliance process
  • SOP review/enhancement committee

Clinical Site Manager Support

Novartis Pharma (Alcon)
2017.01 - 2017.05
  • ETMF ongoing maintenance/reconciliation
  • Ongoing drug reconciliation
  • Order Reg. Doc binders for all sites (initial and resupply)
  • Track medical license expiration and IRB renewal dates (to support on-time drug supplies)
  • Maintain assigned spreadsheets
  • Query distribution to site and/or CRA's
  • Survey Monkey creation and distribution to clinical sites
  • Mailings and other administrative tasks
  • Onboarding for new study staff

Clinical Trials Assistant

Alcon Laboratories Experis-Manpower
2015.11 - 2016.12
  • Assist Clinical Monitoring Leads with clinical processes of maintaining the study workflow, equipment, study aids and Regulatory documents.
  • Ancillary Supplies - Coordinating printing and shipment of study supplies to sites. (CRF's, ISF binders, recruitment materials, training material)
  • Archive- Electronically submit documents Master File.
  • Compliance- Run reports and check archives for critical documents.
  • Internal Processes- Request, receive, review photos/documents, request printing, place in working file, quality oversight.
  • ECG and IVRS- Update enrollment logs/spreadsheets to CTMS add and change vendor contacts.
  • Test Article Reconciliation- Verify count of test article when there are discrepancies.

Document Management Specialist

Smith & Nephew/Kelly Services
2015.08 - 2015.11
  • Document audit and review for submission to TMF, scanning and filing of approved documents.
  • Clerical support for the Clinical Management staff.

Clinical Research Coordinator

Brownstone Clinical Trials
2015.05 - 2015.08
  • Conduct study visit procedures, Informed consent process, drug accountability, phlebotomy, lab specimen processing, HAZMAT shipping, CRF documentation and maintenance, adverse event, and query resolution.
  • IRB correspondence, follow-ups and final reports, protocol deviation and SAE reporting.

Clinical Research Coordinator

Radiant Research
2014.07 - 2015.05
  • Conduct study visit procedures, Informed consent process, drug accountability, phlebotomy, lab specimen processing, HAZMAT shipping, CRF documentation and maintenance, adverse event, and query resolution.
  • IRB correspondence, follow-ups and final reports, protocol deviation and SA reporting.

Clinical Research Assistant

Alcon Laboratories Inc. Experis-Manpower
2011.07 - 2014.07
  • Assist Clinical Monitoring Leads in clinical processes of maintaining the study workflow, equipment, study aids and Regulatory documents.
  • Ancillary Supplies - Coordinating printing and shipment of study supplies to sites. (CRF's, ISF binders, recruitment materials, training material)
  • Archive- Process documents received to submit to Clinical Trial Data Management.
  • Compliance- Run reports and check archives for critical documents.
  • Internal Processes- Request, receive, review photos, request printing, place in working file, quality oversight.
  • EDC and IVRS- Update enrollment logs/spreadsheets to CTMS add and change vendor contacts.
  • Test Article Reconciliation- Verify count of test article when there are discrepancies.

Clinical Research Coordinator Lead

Southwest Rheumatology Research, LLC
2010.09 - 2011.07
  • Submit and maintain financial invoicing quarterly updates for accounts payable/receivables; initiate study interest to pharmaceutical companies; complete site feasibility and submit all pre- and post- study regulatory documents.

Research Director/Clinical Research Coordinator

ProCare Clinical Trials
2008.05 - 2010.09
  • Submit and maintain financial invoicing quarterly updates for accounts payable/ receivables, initiate study interest of pharmaceutical companies: complete site feasibility and submit all pre/ post-study regulatory documents.
  • Recruitment screening charts, scheduling, enrollment, maintain and create source documents per protocol, maintain and document source.
  • Conduct study visit procedures, Informed consent process, drug accountability, phlebotomy, lab specimen processing, HAZMAT shipping, CRF documentation and maintenance, adverse event, and query resolution
  • IRB correspondence, follow-ups and final reports, maintain regulatory binder, protocol deviation and SAE reporting.

Research Lead/ Clinical Research Coordinator

Southwest Rheumatology
2007.07 - 2008.05
  • Submit and maintain financial invoicing quarterly updates for accounts payable/ receivables; initiate pharmaceutical companies’ interest as potential study site; complete site feasibility and submit all pre-and post- study regulatory documents.
  • Recruitment, screening charts, scheduling, enrollment, maintain and create source document per protocol, maintain and document source.
  • Conduct study visit procedures, Informed consent process, drug accountability, phlebotomy, lab specimen processing, HAZMAT shipping, CRF documentation and maintenance, adverse events, and query resolution.
  • IRB correspondence, follow-ups and final reports, maintain Regulatory binder, protocol deviation and SAE reporting.

Clinical Research Coordinator

Bexar Clinical Trials
2006.08 - 2007.07
  • Recruitment, screening charts, scheduling, enrollment, maintain and create source documents per protocol, maintain and document source.
  • Conduct study visit procedures, Informed consent process, drug accountability, phlebotomy, lab specimen processing, HAZMAT shipping, CRF documentation and maintenance, adverse events, and query resolution.
  • IRB correspondence, follow-ups and final reports, maintain Regulatory binder, protocol deviation and SAE reporting.

Clinical Research Coordinator

Galenos Research
2006.03 - 2006.06
  • Recruitment, screening charts, scheduling, enrollment, maintain and create source documents per protocol, maintain and document source.
  • Conduct study visit procedures, Informed consent process, drug accountability, phlebotomy, lab specimen processing, HAZMAT shipping, CRF documentation and maintenance, adverse events, and query resolution.
  • IRB correspondence, follow-ups and final reports, maintain Regulatory binder, protocol deviation and SAE reporting.

Clinical Research Coordinator

Texas Health Research Institute
2006.01 - 2006.03
  • Creating marketing profile presentations for potential research partners.

Clinical Research Coordinator

Urology Clinics of North Texas-THRI
2004.01 - 2005.01
  • Recruitment, screening charts, scheduling, enrollment, maintain and create source documents per protocol, maintain and document source.
  • Conduct study visit procedures, Informed consent process, drug accountability, phlebotomy, lab specimen processing, HAZMAT shipping, CRF documentation and maintaining adverse events, and query resolution.
  • IRB correspondence, follow-ups and final reports, maintain Regulatory binder, protocol deviation and SAE reporting

Clinical Research Coordinator

Renaissance Clinical Research
2002.01 - 2004.01
  • Recruitment, screening charts, scheduling, enrollment maintain and create source documents per protocol, maintain and document source.
  • Conduct study visit procedures, Informed consent process, drug accountability, phlebotomy, lab specimen processing, HAZMAT shipping, CRF documentation, adverse event, and query resolution.
  • IRB correspondence, follow-ups and final reports, maintain Regulatory binder, protocol deviation and SAE reporting.

Workers Compensation and Accident Administrator

Waymon Drummond, MD. I.S.O.M.
1999.01 - 2002.01
  • Evaluate, bill, maintain and process Worker’s Comp claims according to the Texas Worker’s Comp. Guidelines.
  • Assist Dr. Drummond (triage patients gather diagnostic information, pull and file needed medical charts, monitor medication refill.
  • Customer service and resolutions, incoming and outgoing telephone calls, scheduling and collections.

Associate Operations Analyst

PricewaterhouseCoopers, LLC
1996.01 - 1999.01
  • Identify, reconcile, maintain and manually cede and process Bordereau and Non-Bordereau transactions generated from a daily report. (Reinsurance Ceding)
  • Research reporting method, prepare initial, interim, and final loss notices and billing for specific programs of business, maintain and monitor a daily diary as well as respond to inquiries from ceding companies. Intermediaries and Reinsurers. (Reinsurance Claims Reporting)
  • Research claims for billing specifics for incoming cash. Identify premium payments, loss payments, and or expense payments to be booked to the CRO database that entered on the Accounting General Ledger. (Reinsurance Accounting Cash Application)

Education

Business Administration/Management -

Dallas Baptist University
Dallas, TX
01.2017

Licensed - undefined

Texas Cosmetology
TX
01.2002

Business Administration/Management - undefined

Cedar Valley College
Lancaster, TX
01.1992

High School - undefined

Elsie Robertson High School
Lancaster, TX
01.1989

Skills

  • Study progress tracking
  • Informed consent process
  • Adverse event reporting
  • Site monitoring
  • Patient recruitment
  • Data collection
  • Clinical trial administration
  • Subject retention strategies
  • IRB submissions
  • Good clinical practices
  • Research sops understanding
  • Site management
  • Phlebotomy
  • Participant screening
  • Specimen collections
  • Scheduling proficiency
  • Report preparation
  • Records maintenance
  • Meeting coordination
  • Participant recruitment
  • Teamwork and collaboration
  • Problem-solving
  • Attention to detail
  • Leadership skills
  • Multitasking
  • Problem-solving abilities
  • Excellent communication
  • Critical thinking
  • Organizational skills
  • Team collaboration
  • Patient education
  • Safety reporting
  • Patient care coordination
  • Specimen handling
  • Data collection techniques
  • Informed consent
  • Medication dispensing
  • Research experience
  • Trial management
  • Test environment establishment
  • Adverse event tracking
  • Reliability
  • Effective communication
  • Task prioritization

Certification

  • NIDA Clinical trials Network- Good Clinical Practices 05/2022
  • NIH Web-based training Protecting Human Research Participants 05/2022
  • HazMat Transporting 05/2022
  • Joint Assessment Training-Roche 09/2010
  • Certificate of Training Centralized Spirometry Certification 03/2009 Brannan
  • Medical Corp.ToxCup 04/2006
  • Intermediate CRC Training (ACRP) 10/2005
  • Phlebotomy- Venipuncture- Competency Assessment: Observation 09/2005
  • How to Coordinate Clinical Trials 03/2003
  • Shared Care Research and Education Certificate Standardization of Blood Pressure Measurements
  • The Fundamentals of Clinical Research (ACRP) 11/2002

Timeline

Central Study Coordinator/Central Clinical Services

Care Access Research
2022.05 - 2026.03

Operations Manager/Clinical Research Coordinator

Ventavia Research Group
2021.04 - 2022.05

Clinical Trial Document Manager

Greenlight Clinical Trials
2019.10 - 2021.04

Clinical Trial Associate

Smith & Nephew Inc.
2017.05 - 2019.10

Clinical Site Manager Support

Novartis Pharma (Alcon)
2017.01 - 2017.05

Clinical Trials Assistant

Alcon Laboratories Experis-Manpower
2015.11 - 2016.12

Document Management Specialist

Smith & Nephew/Kelly Services
2015.08 - 2015.11

Clinical Research Coordinator

Brownstone Clinical Trials
2015.05 - 2015.08

Clinical Research Coordinator

Radiant Research
2014.07 - 2015.05

Clinical Research Assistant

Alcon Laboratories Inc. Experis-Manpower
2011.07 - 2014.07

Clinical Research Coordinator Lead

Southwest Rheumatology Research, LLC
2010.09 - 2011.07

Research Director/Clinical Research Coordinator

ProCare Clinical Trials
2008.05 - 2010.09

Research Lead/ Clinical Research Coordinator

Southwest Rheumatology
2007.07 - 2008.05

Clinical Research Coordinator

Bexar Clinical Trials
2006.08 - 2007.07

Clinical Research Coordinator

Galenos Research
2006.03 - 2006.06

Clinical Research Coordinator

Texas Health Research Institute
2006.01 - 2006.03

Clinical Research Coordinator

Urology Clinics of North Texas-THRI
2004.01 - 2005.01

Clinical Research Coordinator

Renaissance Clinical Research
2002.01 - 2004.01

Workers Compensation and Accident Administrator

Waymon Drummond, MD. I.S.O.M.
1999.01 - 2002.01

Associate Operations Analyst

PricewaterhouseCoopers, LLC
1996.01 - 1999.01

Licensed - undefined

Texas Cosmetology

Business Administration/Management - undefined

Cedar Valley College

High School - undefined

Elsie Robertson High School

Business Administration/Management -

Dallas Baptist University

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Tracy Williams Reed