Who am I- Positive, passionate, multitasking team member who is always enthusiastic for a challenge! Will always take full advantage of a valuable chance to expand my knowledge/job duty base as I feel this progression is necessary for continued success in this dynamic industry. On the other hand, I am also a very organized and reliant self-starter, able to work independently to properly prioritize and complete tasks without sacrificing quality, customer service or patient care. Integrating my exceptional operational, organization and communication skills together across all facets of a clinical trial, allow me to excel independently and in team orientated environments.
Neogenomics Laboratories, Inc.
2011 -2018
Clinical Trials Study Coordinator
Managed a pipeline of 20+ clinical trial studies, reproducibility studies, special projects
Drafting, editing of SOP’s, SSP’s and other controlled clinical trial documents
Involved in strategizing, structuring and maintaining of project timelines
Tracked the timely completion of document approval and required training
Maintained TMF including regulatory and study specific documentation
Responsible for tracking of clinical trial specimen
Coordinated communication between sponsors, internal/external team and pathologists
Managed pathologists case workflow, QC of completed data per GCP/GDP guidelines
Data Management duties- experienced in detailed SOW and SSP review and drafting of DTA.
QA/QC Representative for Pharma Services
Monitored pending controlled documents and employee training for entire Pharma Services Dept.
Provided bi-weekly controlled document status reports to management
Participate in all department Internal/external audits, monitoring and study close out visits
Process Development Liaison/ Special Projects
Project lead on Pharma Service’s expansion to collaborate with 6 new external/internal lab departments. Completion of this expansion greatly increased the amount and diversity of testing available to the sales team their sponsors/clients, successfully increasing both our value to the customer and company revenue
Project lead on a new and exciting project coined the “Merck MSI by PCR Pilot Study “. The development, execution and completion of pilot study successfully allowed Merck and sponsors to confidently proceed in adding MSI by PCR piggyback testing to multiple closed and open PD-L1 immunotherapy studies greatly increasing Neo’s CT pipeline
As Senior Reproducibility study coordinator, I completed 6 reproducibility studies from start up to close out and closed out, without any major protocol deviations. By successfully obtaining and maintaining the FDA’s confidence, FDA approved immunotherapy treatments can continue to be safely administered to patients
Worked closely with IT, management and medical staff to develop, troubleshoot, and implement a new department wide LIS and data reporting system
Education
Irvine Valley College, BS Health Sciences
Anticipated completion 2020
Anatomy, Physiology, Biology, Microbiology, Chemistry & Physics
UCLA Health Scholar Internship Program
C.C.E. (Critical Care Extender) Direct Patient Care Program- Hoag Presbyterian Hospital
Completed 3-month rotations in Oncology, Telemetry, GI and ER floors
Skills and Knowledge
Very familiar with GDP/GCP/ICH/IRB/FDA guidelines
Strong knowledge of overall clinical trial process
Well versed in IHC, FLOW, FISH, PCR, NGS, Cytogenetics, MultiOmnyx testing methodologies
Microsoft Office 365
Self-starter, highly independent
Positively embrace change, always enjoying the next new challenge
Lover of learning through observation and experience, Driver of constant progression
Highly motivated, consistently responsible and accountable
Professional, organized and highly focused on efficiency, accuracy and attention to detail
Leadership, training and team building experience