Seniore Clinical Research Associate
Resume:
Kathleen Brown, BS Clinical Research Associate *
Rensselaer NY 12144
*****.*********@*****.***
Nineteen years working as a Clinical Research Associate including site management and data management. Prior to that worked at a pharmaceutical research facility for 24 years. Therapeutic experiences in cardiovascular, respiratory/asthma, psychiatry/mood disorders/opioid dependency/ bipolar disorder, neurology/insomnia/pain management, autoimmune/rheumatology/ Crohn's disease. Competent experience with multiple EDC and IXRS systems related to clinical research studies.
Work History
Title Clinical Research Associate 3
Company/Location PRA Health Sciences, Raleigh, North Carolina
Dates Jul 2015- 2017 – Mar 2017
Responsibilities
Conduct Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits.
Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely, query resolution
Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP
Assesses IP accountability, dispensation, and compliance at the investigative sites
Performs essential document site file reconciliation
Phase III ankylosis spondylitis
Title Sr. Clinical Research Associate
Company/Location Worldwide Clinical Trials, Raleigh, North Carolina
Dates Apr 2014- Jul 2015
Responsibilities
Conduct Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits.
Conducted monitoring visit to include Source Document Verification (SDV) vs CRF, and query resolution
Resolved all discrepancies with data in a timely and accurate manner.
Conducted IP Accountability to include reconciliation, receipt, dispensing, and return. Ensured compliancy with storage of study drug.
Accurately maintained and reconciled the Investigator Site File with eTMF
Phase III opioid dependence and Rheumatoid arthritis
Title Senior Clinical Research Associate
Company/Location INC Research, Raleigh, North Carolina
Dates Apr 2013-2014
Responsibilities
Conducted Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits in compliance with GCP and protocol
Conducted monitoring visit to include Source Document Verification (SDV) vs CRF, and query resolution
Conducted IP Accountability to include reconciliation, receipt, dispensing, and return. Ensured compliancy with storage of study drug.
Accurately maintained and reconciled the Investigator Site File with eTMF
Phase II Rheumatoid Arthritis
Title Principal Clinical Research Associate
Company/Location ICON Clinical Research, Philadelphia, Pennsylvania
Dates Sep 2002- Apr 2013
Responsibilities
Conducted Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits.
Conducted all level of monitoring visits in compliance with GCP, applicable local regulations, SOPs and protocol.
Conducted monitoring visit to include Source Document Verification (SDV) vs CRF.
Resolved all discrepancies with data in a timely and accurate manner.
Prepared concise reports to include findings at all site visits in an accurate and timely manner.
Conducted IP Accountability to include reconciliation, receipt, dispensing, and return. Ensured compliancy with storage of study drug.
Accurately maintained and reconciled the Investigator Site File with eTMF.
Demonstrated competency in CTMS, various EDC systems and IVRS systems.
Mentored new CRAs and completed site evaluations.
Title Senior Clinical Research
Company/Location PPD, Austin, Texas
Dates Aug 2001- Sep 2002
Responsibilities
Conducted Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits.
Conducted all level of monitoring visits in compliance with GCP, applicable local regulations, SOPs and protocol.
Conducted monitoring visit to include Source Document Verification (SDV) vs CRF.
Resolved all discrepancies with data in a timely and accurate manner.
Prepared concise reports to include findings at all site visits in an accurate and timely manner.
Conducted IP Accountability to include reconciliation, receipt, dispensing, and return. Ensured compliancy with storage of study drug.
Accurately maintained and reconciled the Investigator Site File with eTMF.
Demonstrated competency in CTMS, various EDC systems and IVRS systems.
Mentored new CRAs and completed site evaluations.
Title Clinical Research Associate II
Company/Location Scirex, Horsham, Pennsylvania
Dates Dec 2000- Jul 2001
Responsibilities
Conducted Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits.
Conducted all level of monitoring visits in compliance with GCP, applicable local regulations, SOPs and protocol.
Conducted monitoring visit to include Source Document Verification (SDV) vs CRF.
Resolved all discrepancies with data in a timely and accurate manner.
Prepared concise reports to include findings at all site visits in an accurate and timely manner.
Conducted IP Accountability to include reconciliation, receipt, dispensing, and return. Ensured compliancy with storage of study drug.
Accurately maintained and reconciled the Investigator Site File with eTMF.
Demonstrated competency in CTMS, various EDC systems and IVRS systems.
Mentored new CRAs and completed site evaluations.
Title Clinical Research Associate II
Company/Location Inveresk, Raleigh, NC
Dates Dec 1999- Dec 2000
Responsibilities
Conducted Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits.
Conducted all level of monitoring visits in compliance with GCP, applicable local regulations, SOPs and protocol.
Conducted monitoring visit to include Source Document Verification (SDV) vs CRF.
Resolved all discrepancies with data in a timely and accurate manner.
Prepared concise reports to include findings at all site visits in an accurate and timely manner.
Conducted IP Accountability to include reconciliation, receipt, dispensing, and return. Ensured compliancy with storage of study drug.
Accurately maintained and reconciled the Investigator Site File with eTMF.
Demonstrated competency in CTMS, various EDC systems and IVRS systems.
Mentored new CRAs and completed site evaluations.
Title Senior Clinical Research Associate
Company/Location Coromed, Troy, New York
Dates Nov 1997- Dec 1999
Responsibilities
Conducted Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits.
Conducted all level of monitoring visits in compliance with GCP, applicable local regulations, SOPs and protocol.
Conducted monitoring visit to include Source Document Verification (SDV) vs CRF.
Resolved all discrepancies with data in a timely and accurate manner.
Prepared concise reports to include findings at all site visits in an accurate and timely manner.
Conducted IP Accountability to include reconciliation, receipt, dispensing, and return. Ensured compliancy with storage of study drug.
Accurately maintained and reconciled the Investigator Site File with eTMF.
Demonstrated competency in CTMS, various EDC systems and IVRS systems.
Title Senior Data Manager
Company/Location Coromed, Troy, New York
Dates Nov 1994- Dec 1997
Responsibilities
Review CRF for accuracy and consistency
Issue Queries for resolve inconsistent data
Review Queries for clarification of data
Title Princpal Research Technician
Company/Location Sterling Winthrop Research Institute
Dates Feb. 1971 – Aug. 1993
Responsibilities
Assist in managing Stability Studies for new investigational product
Monitor and maintain stability chambers
Assist in producing stability reports
Education
Undergraduate, BS Management/Health Education, May 1994
Russell Sage College, Troy, New York
Undergraduate, AAS Management, May 1990
Hudson Valley Community College, Troy, New York
Protocol Therapeutic Experience
Therapeutic Area
Indication Group
Primary Indication
Role
Number of Studies
Duration
Phase
Subject Population
Cardio-Metabolic Diseases
Coronary Artery Disease
CAD
Clinical Research Associate
1
4 mos.
III
Adults
Cardio-Metabolic Diseases
Heart Failure
Chronic Heart Failure
Clinical Research Associate
1
7 mos.
IIB
Adults
Cardio-Metabolic Diseases
Heart Failure
Chronic Heart Failure
Clinical Research Associate
1
1 yr., 6 mos.
III
Adults
Immunology
Autoimmune Disorders
Crohn's Disease
Clinical Research Associate
1
1 yr., 10 mos.
II
Adults
Immunology
Autoimmune Disorders
Rheumatoid Arthritis
Clinical Research Associate
1
6 mos.
II
Adults
Immunology
Autoimmune Disorders
Rheumatoid Arthritis
Clinical Research Associate
1
1 yr., 1 mo.
III
Adults
Musculoskeletal
Muscle Spasm
Muscle Spasm (general)
Clinical Research Associate
1
7 mos.
Not Applicable
Adults
Musculoskeletal
Ankylosis spondylitis
Spine
Clinical Research Associate
1
1 yr.
III
Adults
Neurology
Pain
Fibromyalgia
Clinical Research Associate
1
8 mos.
II
Adults
Neurology
Pain
OA/RA
Clinical Research Associate
1
1 yr.
Not Applicable
Adults
Neurology
Pain
Post-Operative Pain
Clinical Research Associate
1
7 mos.
IIB
Adults
Neurology
Sleep Disorders
Insomnia
Clinical Research Associate
1
6 mos.
III
Adults
Psychiatry
Mood Disorders
Bipolar I Disorder
Clinical Research Associate
1
10 mos.
III
Adults
Psychiatry
Mood Disorders
Major Depressive Disorder
Clinical Research Associate
2
2 yrs., 7 mos.
III
Adults
Psychiatry
Mood Disorders
Major Depressive Disorder
Clinical Research Associate
1
2 yrs.
IIIB
Adults
Psychiatry
Substance Use Disorders
Opioid
Clinical Research Associate
1
9 mos.
III
Adults
Respiratory
Asthma
Mild/Mod Asthma
Clinical Research Associate
1
2 yrs., 11 mos.
IV
Adults
Pediatrics
Environment Experience
Environment
Therapeutic Area
Subject Population
Doctor's Office
Psychiatry, Neurology, Immunology, Musculoskeletal, Cardio-Metabolic Diseases
ADULTS
In-patient
Neurology
ADULTS
Out-patient
Neurology, Respiratory
ADULTS, PEDIATRICS
System Experience
Type
System Name
Clinical Trial Management Systems
eClinical, IMPACT CTMS
EDC
Medicate RAVE, Oracle Inform
IVRS/IWRS/RTSM
UBC, ClinPhone IVRS
Vendor Experience
Type
Name
EDC / dairy / e-PRO
Mediate RAVE, Eco’s, Informs
IRB
Quorum, Copernicus
IXRS
echoes, SGS
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