Research Associate Clinical
Resume:
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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