Clinical Research Data Analyst
Resume:
JENNIFER NAM
******@*****.*** **** W Dickens Ave Apt 1, Chicago
www.kickresume.com/cv/jnam/
J N
Senior Clinical Research Coordinator with 13+ years of extensive experience providing support, coordination, and leadership for Phase I, II, and III oncology clinical trials involving immunotherapies, targeted therapies, precision medicine, and cellular therapies including allogeneic and hematopoietic stem cell transplants. Senior Clinical Research Analyst 04/2019 – present University of Chicago, Chicago, Illinois
Responsible for all aspects of Neurology research projects and research facilities. Plans and conducts clinical and non-clinical research; facilitates and monitors daily activities of clinical trials or research projects. Directs engineering and technical support activities to develop and maintain tools and computational methods needed to gather and analyze data. Requires knowledge and experience in own discipline; still acquiring higher-level knowledge and skills. Builds knowledge of the organization, processes and customers.
Solves a range of straightforward problems. Analyzes possible solutions using standard procedures.
Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits. Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits.
Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study. Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility Senior Clinical Research Coordinator 09/2014 – 12/2018 University of Chicago, Chicago, Illinois
Oversaw the startup and execution of new studies
Maintained 55 Stem Cell Transplant, Hematologic and Neuro-Oncology trials as principal research coordinator
Developed and wrote protocols for therapeutic, prevention, genetic, and quality of life trials
Extracted and analyzed data from multiple formats and databases for use in abstracts, posters, and publications with co-authorship Coordinated with cross-functional teams of physicians; statisticians; genomics, cytogenetics, and stem cell labs; and apheresis, chemotherapy infusion and pharmacy staff
Primary liaison between research clinicians and Next-Generation Sequencing laboratories being used to profile and manage hematological malignancies Presented progress and clinical outcomes at weekly department meetings involving all research staff and principal investigators
Performed daily reviews of monitor compliance; lead virtual meetings and training sessions; and create monthly and quarterly monitoring metrics presentations for project and monitoring management teams
Clinical Data Analyst 06/2014 – 09/2014
AbbVie, North Chicago, Illinois
Oversaw database design, development and implementation for assigned oncology Profile
Experience
clinical trial projects
Ensured that data security and integrity was maintained Developed all aspects of Clinical Data Management work products including database tables, code lists, data capture screens and tools, edit check programs, reports, listings and output
Performed data extraction, aggregation, and complex analyses using SQL Devised, documented and implemented validation test plans for various database and data collection components
Generated reports to facilitate study team review and validation of data Maintained Data Management Plans, CRF and Edit Specifications across multiple platforms (e.g. EDC, IRT, and ePRO), Data Dictionaries, Edit Check Definitions, and Analysis Output Definitions
Research Project Manager 11/2013 – 05/2014
Northwestern University, Chicago, Illinois
Managed and supported a diverse team that included budget, contract, regulatory, and research specialists
Provided complex scientific and technical leadership in determining research priorities as well as planning, designing and executing research projects ensuring that the hematologic malignancies and stem cell transplant programs met their specified goals
Developed and implemented new processes (e.g. 8 week startup time for all clinical trials) and protocols to support hematologic cancer research studies and to maximize/extend study capabilities
Maintained project data including extraction, accuracy verification, and analysis ensuring that results met project information and deliverable objectives Created data for use in grant submissions and developed new proposals for research including obtaining financial support
Presented startup metrics at weekly project status meetings Acted as a liaison between institutional investigators, cooperative group and industry sponsors, operations offices, and statistical centers Clinical Data Manager II 08/2010 – 05/2014
Northwestern University, Chicago, Illinois
Oversaw all tasks involved in site initiations, monitoring, and close-out visits for over 40 therapeutic oncology clinical trials for hematologic malignancies Assessed protocol compliance and reported study deviations when identified Mentored and trained new personnel
Created and validated eCRFs
Clinical Research Associate II 05/2008 – 08/2010
University of Chicago, Chicago, Illinois
Screened, scheduled, and monitored subjects in over 20 investigator-initiated and pharmaceutical oncology trials
Participated in a large scale Radiology pilot program Trained and advised new staff
Completed grant applications
Clinical Research Associate II 10/2005 – 11/2007
East-West Medical Research Institute, Honolulu, Hawaii Assisted the Principal Investigator with running trials involving metabolic and endocrine diseases e.g. diabetes, gout, and obesity Transcribed clinical data into pharmaceutical EDC system Completed all regulatory documents for IRB submission Scheduled and conducted site initiations, monitoring, and close-out visits Biology 09/2001 – 03/2006
University of Chicago, Chicago, Illinois
Experience
Education
Experience and expertise
with Clinical Data
Management systems
and relational database
management systems
including SQL
Knowledge of GCDMP,
GCP, ICH guidelines
Extensive project
development and team
supervision
Strong understanding of
process analysis and
management
Advanced knowledge of
multiple hematologic
and oncologic disease
fields
Substantial data
management experience
Excellent interpersonal
and communication
skills
Completes work with a
high degree of
proficiency and
autonomy
High Rate of Sustained Minimal Residual Disease Negativity Predicts Prolonged Survival for the Overall Patient Population in the Phase 2 KRd Plus Autologous Stem Cell Transplantation MMRC Trial
12/2017
Blood
http://www.bloodjournal.org/content/130/Suppl_1/4533?sso-checked=true Final Results of a Phase 2 Trial of Extended Treatment (tx) with Carfilzomib (CFZ), Lenalidomide (LEN), and Dexamethasone (KRd) Plus Autologous Stem Cell Transplantation (ASCT) in Newly Diagnosed Multiple Myeloma (NDMM) 12/2016
Blood
http://www.bloodjournal.org/content/128/22/675
Final Results of Phase 1 MMRC Trial of Selinexor, Carfilzomib, and Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM)
12/2016
Blood
http://www.bloodjournal.org/content/128/22/973
Phase 1/2 study of carfilzomib, pomalidomide, and dexamethasone (KPd) in patients
(Pts) with relapsed/refractory multiple myeloma (RRMM): A Multiple Myeloma Research Consortium multicenter study
05/2016
Journal of Clinical Oncology
http://ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.8007 Carfilzomib (CFZ, Kyprolis®), Lenalidomide (LEN, Revlimid®), and Dexamethasone
(DEX) (KRd) Combined with Autologous Stem Cell Transplant (ASCT) Shows Improved Efficacy Compared with Krd without ASCT in Newly Diagnosed Multiple Myeloma
(NDMM)
03/2016
Biology of Blood and Marrow Transplantation
https://doi.org/10.1016/j.bbmt.2015.11.320
Core Qualifications
Publications
Phase 1 MMRC Trial of Selinexor, Carfilzomib (CFZ), and Dexamethasone (DEX) in Relapsed and Relapsed/Refractory Multiple Myeloma (RRMM) 12/2015
Blood
http://www.bloodjournal.org/content/126/23/4223
Phase II trial of sunitinib in medullary thyroid cancer (MTC) 05/2010
Journal of Clinical Oncology
http://ascopubs.org/doi/abs/10.1200/jco.2010.28.15_suppl.5504 Certificate of Completion for Viral Vectors
03/2017
University of Chicago
Certificate of Completion for Shipping Infectious Substances 10/2014
University of Chicago
Certificate of Completion in Human Research
10/2014
CITI Program
Certificate of Completion in CITI Good Clinical Practice 09/2017
CITI Program
Certificate of Completion in Responsible Conduct of Research 05/2016
CITI Program
Publications
Certificates
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