Amber Graham
Research Program Lead - Thoracic & GI
Katy,TX
Summary
I have experience in both pre-clinical and clinical research with the majority of my career having been spent in oncology clinical operations. I have a good understanding of the fundamentals of research study design and data analysis. I am an well versed in operational considerations for study conduct. I've worked in pediatric and adult oncology as a coordinator with direct patient contact in both hospital and outpatient academic centers as well as in community practice. I have experience with project level oversight of clinical trials within an oncology network. Most recently, I have been managing multiple disease programs for US Oncology (Sarah Cannon Research Institute) in collaboration with physician committees. Within each program I manage teams of project managers and have oversight of all the trials withing Thoracic and Gastrointestinal programs. I am looking to advance my career in Oncology Clinical Research by offering my expertise to Pharmaceutical companies to assist in effective trial design for clinical practice and best recruitment. I enjoy managing teams and collaborating cross-functionally.
Overview
10
10
years of professional experience
5
5
years of post-secondary education
Work History
Research Program Lead
Sarah Cannon Research Institute
The Woodlands, TX
11.2021 - 08.2023
- Collaborate with multiple support teams to create successful and varied clinical trial programs
- Facilitate exchange of expertise between Network physician leaders and pharmaceutical industry partners
- Plan disease specific meeting agendas to review and analyze and upcoming clinical trials for scientific merit, study design, operational requirements in order to determine feasibility for network participation.
- Communicate closely with business development team to address concerns for study conduct
- Strategize support of multiple clinical trials in competing space
- Analysis of appropriate site selection for feasibility based on geography, data, physician engagement and other factors to present best capabilities to industry sponsor.
- Determine overall network accrual target
- Evaluate long-term participation and communicate effectively with pharmaceutical partners about identified gaps and propose solutions when necessary.
- Lead Industry and Network meetings at national conferences to discuss disease specific pipeline and feasibility of trial design for network participation (American Society of Clinical Oncology, Chicago, IL).
- Personnel Management: Team of 8 individuals consisting of three levels/job descriptions. Payroll, onboarding, hiring, reviews, disciplinary action, training and career growth support.
- Plan and host internal department meetings with other Program Leaders
- Collaboration with Quality Assurance and Compliance teams to improve process and implement best practice.
- Collaborate with IT project management to map ongoing processes and identify gaps and propose solutions.
Clinical Trial Manager
US Oncology McKesson
The Woodlands, TX
08.2020 - 11.2021
- Meet regularly with sponsor/CRO partner project management teams
- Maintain partnerships and open communication with sponsor/CRO
- Discuss and strategize how to overcome enrollment barriers
- Manage site issues and risk mitigation
- Protocol review and communication with sponsor regarding needed updates for amendments
- Site support with finance issues
- Budget analysis and review with finance team
- Completion of start-up activities after transfer of trial to execution
- Planning for trial implementation with site services when necessary
- CTMS Document management
- Training document management
- Monthly study reports with deviation and SAE reviews
- Solution innovation with respect to project management, SharePoint Teams projects
- Present to physician committees on on trial metrics and barriers
- Approval of Screen Fail Invoicing
- Mentor team members and others
Study Manager
Elligo Health Research
01.2019 - 08.2020
- Overall Site Management (Multiple Sites)
- Assist Principal Investigator in ongoing trial conduct
- Facilitate Initiation and Conduct of Clinical Research Trials
- Actively Screen and Recruit New Patients For Open Treatment and Registry Trials
- Ensure site readiness for and conduct Site Selection, Initiation, Monitoring visits.
- Review Needs for Upcoming Trials and Ensure Contracting and Equipment Are Available Prior to SIV
- Innovate solutions to unmet needs including vendor contract and training
- Training Site Staff on New and Upcoming Trials
- Electronic Data Capture and Electronic Medical Record Navigation
- Clinical Trial Patient and Visit Management - From consent to completion of follow-up
- Meet weekly with Principal and Treating Investigator to review patient responses, SAE's, goals, etc.
- Regulatory Binder Management with Florence eBinders
- Maintain excellent communication with sponsors and CRO's regarding screening and enrolled patients
Clinical Research Coordinator II
Rocky Mountain Cancer Centers
11.2017 - 01.2019
- Phase I/II/III: Screening and Consenting Patients for Treatment and Registry Studies
- Training Site Staff on New and Upcoming Trials
- Site Selection Visit Conduction
- Electronic Data Capture and Electronic Medical Record Navigation
- Conduct patient visit: Orders including scans, laboratory tests, EKG, etc.
- Document accurately in the EMR Adverse Events along with Grade
- Meet regularly with Principal and Treating Investigator to review patient responses, SAE's, goals, etc.
- Site Initiation Visit Attendance: Both local and remote
- Monthly Oversight Call: Related SAE review with Study Investigators
- Assisting Investigators with Completing Review/Signatures needed in Florence for Regulatory Compliance
- Collect and ship central labs as appropriate per protocol guidelines
- IVRS Randomization, ordering and status changes
- Deviation Reporting
- Consistently meeting data lock requirements
- Timely Query Resolution
- Maintain excellent communication with sponsors and CRO's regarding screening and enrolled patients
Clinical Research Coordinator
Children's Hospital Colorado
Aurora, CO
06.2015 - 11.2017
- Phase II/III: Screening patients and facilitating consent process with site clinical staff
- Enrollment and status change via IVRS or Consortium Site as appropriate
- Electronic Data Capture and Medical Chart Review
- Deviation Reporting
- Attend conference and tumor board for liquid and solid tumor teams, provide guidance to MD's as to open and available studies
- Present process improvement ideas to Principal Investigator
- Assist with monitoring visits as needed
Professional Research Assistant
University Of Colorado, Department Of Pediatrics
Denver, CO
10.2013 - 06.2015
- Murine Oncology Model Experiment Set Up, Execution and Take Down
- Xenograft Establishment & post engraftment antigen expression profile
- Preservation of primary human specimen for experimentation
- Inventory of resource for grant inclusion
- Budget Management
- Data Analysis & Presentation
Education
Bachelor of Science - Chemistry And Biology
Metropolitan State University of Denver
Denver, CO 01.2008 - 05.2013
Skills
Team collaboration and leadership
Timeline
Research Program Lead
Sarah Cannon Research Institute
11.2021 - 08.2023
Clinical Trial Manager
US Oncology McKesson
08.2020 - 11.2021
Study Manager
Elligo Health Research
01.2019 - 08.2020
Clinical Research Coordinator II
Rocky Mountain Cancer Centers
11.2017 - 01.2019
Clinical Research Coordinator
Children's Hospital Colorado
06.2015 - 11.2017
Professional Research Assistant
University Of Colorado, Department Of Pediatrics
10.2013 - 06.2015
Bachelor of Science - Chemistry And Biology
Metropolitan State University of Denver
01.2008 - 05.2013
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