David Qian
Seattle
Summary
I aspire to expand my clinical research experience by working as a {Job Title} at {Institution Name}, contributing to a team that advances cancer treatment. As an accomplished clinical science professional with ten years of experience, I have a strong passion for cancer research. I have successfully managed up to eight studies simultaneously, maintaining an average caseload of six active patients per month. Additionally, I have played a key role in training new clinical research coordinators, offering guidance for their professional development, and improving the organization's onboarding process. I am a strong speaker and presenter, with extensive experience in both clinical and academic research. Well-versed in Good Clinical Practice (GCP) standards and regulatory affairs, I hold certifications from the Society of Clinical Research Associates (SOCRA), and the International Air Transport Association (IATA). My experience includes preparing for and assisting with FDA audits for new drug applications, reviewing patient charts, responding to auditor inquiries, and addressing compliance concerns. I am eager to bring my expertise and dedication to your team, and contribute to groundbreaking advancements in cancer research.
Overview
16
16
years of professional experience
Work History
Clinical Research Coordinator III
IIRC’s Clinical Trial Office at Fred Hutchinson Cancer Center
Seattle
02.2024 - Current
- Specializing in Cellular Immunotherapy studies using CAR-T, TCR, and TIL cells to treat advanced cancers, I collaborate with various teams to manage industry clinical trials and investigator-initiated trials (IIT) to treat liquid and solid tumors
- Responsibility to prepare for, attend, take active role in FDA Audits, and for the upkeep of essential documents (i.e., pill diary, temperature log, etc.) to help keep the team FDA audit ready at all times
- Help train new coordinators during onboarding and going forward as needed
- Reviewed new protocols for study startup at institution
- Provide inputs about changes to improve the running of our IIT for upcoming protocol amendments
- Prepare for, attend, and take an active role in FDA audits
- Coordinates services, schedules procedures, creates and maintains case packages, and monitors charges
- Collaborating with the Finance Team, Apheresis Team, Pathology Team, Bezos Immunotherapy Clinic, and UWMC inpatient team to help manage patient’s care during research treatment
- Assist the PI with informed consents of study patients and reviewing their consent note to make sure it comply with FDA requirements
- Representing the IIRC CRO team in our institution’s continued education committees
- This includes pitching ideas to improve the onboarding process for new CRCs and speaking about clinical research at undergraduate internship programs that Fred Hutchinson Cancer Center hosts during the summer
- Notable outcomes include: The FDA approval of Bryanzi (liso-cell) for adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) through our work on NCT03331198 (TRANSCEND CLL 004)
- The accelerated approval of Bryanzi (liso-cell) for adults with relapsed or refractory Follicular Lymphoma (FL) after two prior lines of therapy through our work on NCT04245839 (TRANSCEND FL)
Clinical Research Coordinator I
Clinical Trial Office at Emory’s Winship Cancer Institute
Atlanta
08.2014 - 07.2018
- Conducted Phase 2 and 3 clinical trials for Melanoma cancers under the Melanoma & Neuro
- Oncology team
- During my tenure, I coordinated IL-2, Ipilimumab + Nivolumab, and vaccine trials
- Handles administrative activities associated with the conduct of clinical trials like administer MMSE testing
- Assists with patient recruitment and managing patient’s research charts (shadow charts)
- Conducting informed consents with the study PI
- Collects study specimens according to protocol which include processing and preparation for shipping
- Orders and maintains equipment and supplies
- Coordinates services, schedules procedures, creates and maintains case packages, and monitors charges
- Checks data from completed forms or other documents for accuracy and completeness and enters into the database
Data Entry Specialist
Clinical Trial Office at Emory’s Winship Cancer Institute
Atlanta
08.2013 - 08.2014
- I worked within Melanoma & Neuro
- Oncology team and was trained in Good Clinical Practice methods
- It was an excellent entry-level role for new staff wishing to enter clinical research
- Checked data from completed forms or other documents for accuracy and completeness and entered into the database
- Reviewed audit reports and resolved errors to ensure integrity of data
- Identified problems with database management policies and procedures and provided input into their revision
- Assisted the clinical research coordinator by: Identifying and log protocol deviations through a patient’s study treatment course, based on the protocol’s requirement
- Identifying and log Adverse Events (AE) through a patient’s study treatment course, based on the protocol’s requirement
- Maintaining a disease assessment response log for each patient on the study, based on the protocol’s requirement
- Assisted in the training of other data entry employees on data entry and the distribution of reports
Research Assistant
Dr. William “Bill” Walthall Lab
Atlanta
01.2009 - 08.2013
- Studying the role of nature and nurture during development, we used C
- Elegans as our model organism
- I developed methods of observing and measuring mutant behaviors for quantitative analysis, which required me to be cross-functional and willing to explore new laboratory techniques
- Investigated C
- Elegans locomotion, with an emphasis on uncoordinated mutants and double mutants
- Conducted complementation tests to assess the allelic makeup of the progeny of mutant crosses
- Gather C
- Elegans locomotion movies by using confocal, DeltaVision, and UV microscopy techniques
- Operated Matlab program that quantitatively measures C
- Elegans locomotion
- Interpreted the quantitative data generated from the Matlab programs
- Utilized standard laboratory protocol such as cell culture, C
- Elegans culture, microscopy, complementation test, equipment sanitation, maintenance, and restocking of supplies
Education
Bachelor of Arts - Political Science
Georgia State University
Atlanta, GA12.2013
Bachelor of Science - Biology
Georgia State University
Atlanta, GA12.2012
Skills
- TAO
- InForm
- RAVE
- EPIC
- PowerChart
- OnCore
- Florence
- ERMS
- CTEP
- Clario
- SPSS
- Microsoft Office
- Adobe Acrobat Pro
- 12 lead ECG
- CPR
- MMSE test
- Cancer Cell Isolation processing
- Serum isolation processing
- CCRP certified
Qualifications
TAO, InForm, RAVE, EPIC, PowerChart, OnCore, Florence, ERMS, CTEP, Clario, SPSS, Microsoft Office (Word, PowerPoint, Excel), Adobe Acrobat Pro, perform 12 lead ECG, CPR, administer MMSE test, Cancer Cell Isolation processing, serum isolation processing, CCRP certified (2017)
Timeline
Clinical Research Coordinator III
IIRC’s Clinical Trial Office at Fred Hutchinson Cancer Center
02.2024 - Current
Clinical Research Coordinator I
Clinical Trial Office at Emory’s Winship Cancer Institute
08.2014 - 07.2018
Data Entry Specialist
Clinical Trial Office at Emory’s Winship Cancer Institute
08.2013 - 08.2014
Research Assistant
Dr. William “Bill” Walthall Lab
01.2009 - 08.2013
Bachelor of Arts - Political Science
Georgia State University
Bachelor of Science - Biology
Georgia State University
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