Judy Oster

Senior Clinical Research Associate

Los Angeles, CA, USA

Education

Pepperdine University

MA, Psychology

University of Utah

BS, Biology

Summary

Over 25 years of experience working in clinical research positions including study sites, biopharmaceutical companies and clinical research organizations. And over 20 years of experience as a Senior CRA. Over six years of experience as a Lead CRA.

Clinical Research Therapeutic Areas include:

NeuroScience

Alzheimer’s Phase 3

Multiple Sclerosis Phase 3

Parkinson’s Phase 3

CardioMetabolic

Hypertension Phase 2 and 3

Congestive Heart Failure Phase 1

Psychiatry

Anxiety Phase 3

Bipolar Phase 3

Schizophrenia Phase 3

Rare Disorders

Duchenne Muscular Dystrophy Phase 1

Amyotrophic Lateral Sclerosis Phase 1 and 2

Infectious Disease

HIV Phase 1,2 and 3

Oncology

Solid Tumors/Breast Phase 1 and 2

Solid Tumors/Prostrate Phase 1

Solid Tumors/Pancreas Phase 1

Solid Tumors/Melanoma Phase 1

Solid Tumors/NSCLC Phase 1 and 2

Multiple Myeloma/Phase 2

ER positive HER negative Breast Cancer with Bone

Metastasis/Phase 1b

Advanced Non-Small Cell Lung Cancer/Phase 3

Hematologic Malignancies

Leukemia Phase 1

Ophthalmology

Glaucoma Phase 1,2 and 3

Dry Eye and Conjunctival Syndromes Phase 3

Skills

Experience in Electronic Data Capture trials: InForm and RAVE

Languages: English

Professional Experience

Worldwide Clinical Trials

Senior Clinical Research Associate January 2022 to Present

Manage investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, WWCT SOPs/WPs, applicable regulations and the principles of ICH-GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of WWCT systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.

Study Assignment

ALS

Phase 1 and 2

Responsibilities:

Countries handled (No. of sites): US (4 sites)

Study stages handled: Initiation and Interim

IQVIA Biotech

Senior Clinical Research Associate August 2019 to January 2022

Manage investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, IQVIA SOPs/WPs, applicable regulations and the principles of ICH-GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of IQVIA systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.

Study Assignment

NSCLC

Phase 1

Responsibilities:

Countries handled (No. of sites): US (6 sites)

Study stages handled: Interim

ICON Clinical Research

Senior Clinical Research Associate April 2016 to August 2019

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.

Study Assignment

Multiple Myeloma

Phase 1b

Responsibilities:

Countries handled (No. of sites): US (5 sites)

Study stages handled: Start-up through interim

Advanced Non-Small Cell Lung Cancer

Phase 3

Responsibilities:

Countries handled (No. of sites): US (3 sites)

Study stages handled: Start-up through interim

Advanced Non-Small Cell Lung Cancer

Phase 1b

Responsibilities:

Countries handled (No. of sites): US (1 site)

Study stages handled: Start-up through interim

Covance Clinical Development Services

Contract, Senior Clinical Research Associate Nov 2015 to Mar 2016

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors, and other duties as assigned. Responsible for all aspects of site management as prescribed in the project plans.

General On-Site Monitoring Responsibilities:

Source data verification

Identify and resolve issues

Regulatory File review

Drug accountability

Safety review

Query resolution

ICF review

Study Assignment

ER positive HER negative Breast Cancer with Bone Metastasis

Phase 1b

Responsibilities:

Countries handled (No. of sites): US (18 sites)

Study stages handled: Start-up through interim

InVentiv on assignment to Capricor

Senior Clinical Research Associate Mar 2015 to Nov 2015

Monitored the participant study sites, as laid out in ICH/GCP chapter 5.18 ‘Monitoring’

Developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities.

Conducted site management activities that included but were not limited to site selection visits, site initiation visits, site training, site routine monitored visits, and site close out visits.

General On-Site Monitoring Responsibilities:

Source data verification

Identify and resolve issues

Regulatory File review

Drug accountability

Safety review

Query resolution

ICF review

Study Assignment

Congestive Heart Failure, Phase 1b

Stem Cell, Phase 1b

Responsibilities:

Countries handled (No. of sites): US (5 sites)

Study stages handled: Start-up through interim

PRA Health Sciences

Senior Clinical Research Associate Nov 2014 to Mar 2015

Developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities

Conducted site management activities that included but were not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.

General On-Site Monitoring Responsibilities:

Source data verification

Identify and resolve issues

Regulatory File review

Drug accountability

Safety review

Query resolution

ICF review

Study Assignment

Solid Tumors

Breast/Lung/Melanoma

Phase 1 and 2

Responsibilities:

Countries handled (No. of sites): US (5 sites)

Study stages handled: Interim

Allergan

Lead Clinical Research Associate Jun 2012 to Nov 2014

Provided oversight on monitored activities associated with the site-level feasibility, evaluation, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites in the therapeutic area assigned.

Acted as the first line of contact between the study team and the field-based monitors

Attend and participated in study team calls as the GMO representative. Conduct monitor meetings.

Collaborated, coordinated and provided study specific training to monitors and sites.

Conducted training of monitoring plan, CRF completion and other monitoring tools at Monitor and Investigator Meetings, as well as ongoing training opportunities.

Study Assignment

Ophthalmology

Glaucoma

Phase 1, 2 and 3

Responsibilities:

Countries handled (No. of sites): US (50 sites)

Study stages handled: Start-up, Interim, Close-out

RPS on assignment to Allergan

Senior Clinical Research Associate Jun 2011 to Jun 2012

Developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities

Conducted site management activities that included but were not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.

General On-Site Monitoring Responsibilities:

Source data verification

Identify and resolve issues

Regulatory File review

Drug accountability

Safety review

Query resolution

ICF review

Study Assignment

Ophthalmology

Glaucoma

Phase 1, 2 and 3

Responsibilities:

Countries handled (No. of sites): US (17 sites)

Study stages handled: Start-up, Interim, Close-out

CytRx Corporation

Senior Clinical Research Associate Nov 2009 to Jun 2011

Developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities

Conducted site management activities that included but were not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.

General On-Site Monitoring Responsibilities:

Source data verification

Identify and resolve issues

Regulatory File review

Drug accountability

Safety review

Query resolution

ICF review

Study Assignment

Solid Tumors

Lung/Pancreas/Prostate

Phase 1 and 2

Responsibilities:

Countries handled (No. of sites): US (17 sites)

Study stages handled: Start-up, Interim, Close-out

Lugene Eye Institute

Lead Study Coordinator Apr 2008 to Nov 2009

Conducted subject evaluations for multiple drug studies

Monitored and documented subject’s progress in studies that included source document, CRF completion, regulatory documentation and drug accountability

Drew, processed and shipped blood samples

Completed queries

Developed recruitment plans for multiple studies

Actively sought new studies

Study Assignment

Ophthalmology

Dry Eye/Conjunctivas

Phase 1, 2 and 3

Responsibilities:

Study stages handled: Start-up, Interim, Close-out

Independent Contractor

Contract Clinical Research Associate May 2002 to Mar 2008

Developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities

Conducted site management activities that included but were not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.

General On-Site Monitoring Responsibilities:

Source data verification

Identify and resolve issues

Regulatory File review

Drug accountability

Safety review

Query resolution

ICF review

Study Assignment

CardioMetabolic and Infectious Disease

Phase 3

Responsibilities:

Countries handled (No. of sites): US (average 16 sites)

Study stages handled: Start-up, Interim, Close-out

Quintiles

Associate Scientist Jan 2000 to May 2002

Developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities

Conducted site management activities that included but were not limited to site selection visits, site initiation visits, site training, site routine monitored visits, and site close out visits

Ensured the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines

Established and maintained good rapport with study sites

Wrote study visit reports and followed-up with letters within the timeline established by applicable SOPs and guidelines

Followed-up of drug safety issues and safety reports in timely manner, if applicable

Communicated site study issues, concerns, and progress to Project Manager, Clinical Team Lead, Regional Monitoring Manager and Clinical Operations Manager accordingly

Study Assignment

Bipolar Disorder

Phase 3

Responsibilities:

Countries handled (No. of sites): US (23 sites)

Study stages handled: Interim, Close-out

The Phoenix

Senior Clinical Research Associate Jan 1999 to Jan 2000

Developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities

Conducted site management activities that included but were not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.

General On-Site Monitoring Responsibilities:

Source data verification

Identify and resolve issues

Regulatory File review

Drug accountability

Safety review

Query resolution

ICF review

Study Assignment

Cardiometabolic

Phase 3

Responsibilities:

Countries handled (No. of sites): US (average 15 sites)

Study stages handled: Start-up, Interim, Close-out

Scirex

Senior Clinical Research Associate Jan 1997 to Jan 1999

Developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities

Conducted site management activities that included but were not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.

General On-Site Monitoring Responsibilities:

Source data verification

Identify and resolve issues

Regulatory File review

Drug accountability

Safety review

Query resolution

ICF review

Study Assignment

Social Anxiety and Schizophrenia

Phase 3

Responsibilities:

Countries handled (No. of sites): US (average 16 sites)

Study stages handled: Start-up, Interim, Close-out

Quintiles

Clinical Research Associate Aug 1995 to Jan 1997

Developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities

Conducted site management activities that included but were not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.

General On-Site Monitoring Responsibilities:

Source data verification

Identify and resolve issues

Regulatory File review

Drug accountability

Safety review

Query resolution

ICF review

Study Assignment

CNS

Phase 3

Responsibilities:

Countries handled (No. of sites): US (average 15 sites)

Study stages handled: Start-up, Interim, Close-out

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