Resume

Sign in

Clinical Trial Study Coordinator

Location:
Costa Mesa, California, 92627, United States
Posted:
February 08, 2019

Contact this candidate

Resume:

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



Contact this candidate