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Jessica Claire
Montgomery Street, San Francisco, CA 94105
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Websites, Portfolios, Profiles
Professional Summary
  • Detailed, reliable and results-driven professional with over 10 years of research experience and 5 years of drug safety experience
  • Ability to work independently and make autonomous decisions while still being an integral team player in effort to support a unified outcome
  • Passion for clinical research and familiarity with several indications including: Oncology, Dermatology, Aesthetic medical devices and Behavioral sciences

 

 

Skills

Experience with:

  • Managing the ARISg safety cloud platform
  • Vendor selection, contract negotiation, audits and management
  • Managing drug safety operations & employees
  • Presenting at Investigator Meetings

Knowledge of:

  • Strong knowledge of clinical drug safety/GVP regulations (FDA/EMEA)
  • GCP, ICH, MedDRA, CTCAE
  • Medical Terminology
  • Human subject research regulations
Work History
02/2016 to Current
Senior Drug Safety Associate Beigene, Ltd. Apac Australia, MS,

Duties:

  • Responsible for day-to-day drug safety operations, including the management of in-house Serious Adverse Event (SAE) case processing and external pharmacovigilance vendors
  • Oversee the hiring, training and management of drug safety operations staff
  • Act as the safety database (ARISg) administrator working with ARISg to execute system upgrades, conduct user administration testing (UAT) and review data outputs and system reports
  • Responsible for the drafting and/or review of SAE case narratives, SUSAR reports (e.g. CIOMS/MedWatch), Clinical Study Report (CSR) patient narratives
  • Serve as the drug safety/pharmacovigilance subject matter expert, providing drug safety guidance for product and/or study specific audits
  • Develop and maintain drug safety Standard Operating Procedures (SOPs)/job aids/work instructions, safety management plans, company SAE report form template
  • Assist in the review of annual regulatory safety information (e.g. DSUR, Investigator's Brochure) as well as assist with any ad-hoc regulatory questions specific to drug safety
  • Closely collaborate with Data Management on SAE reconciliation issues

Key Accomplishments:

  • Led and managed the successful transition of all pharmacovigilance management operations for two, ongoing global phase III clinical trials from OncoGenex's former partner to a new drug safety vendor on time, on budget and with no impact to clinical operations.

06/2013 to 01/2016
Drug Safety Associate Amag Pharmaceuticals, Inc. Monmouth Beach, NJ,

Duties:

  • Responsible for day-to-day drug safety operations, including the management of in-house Serious Adverse Event (SAE) case processing and external pharmacovigilance vendors
  • Oversaw the hiring, training and management of drug safety operations staff
  • Acted as the safety database (ARISg) administrator working with ARISg to execute system upgrades, conduct user administration testing (UAT) and review data outputs and system reports
  • Responsible for the drafting and/or review of SAE case narratives, SUSAR reports (e.g. CIOMS/MedWatch), investigational product Reference Safety Information (RSI)
  • Served as the drug safety/pharmacovigilance subject matter expert, providing drug safety guidance for product and/or study specific audits
  • Developed and maintained drug safety SOPs/job aids/work instructions, safety management plans, company SAE report form template
  • Assisted in the review of annual regulatory safety information (e.g. DSUR, Investigator's Brochure) as well as assist with any ad-hoc regulatory questions specific to drug safety
  • Closely collaborated with Data Management on SAE reconciliation issues

Key Accomplishments:

  •  Developed the entire drug safety department at OncoGenex including the implementation of new processes, procedures, safety database and structuring the Pharmacovigilance Master Files.
  • Promoted into Senior Drug Safety Associate
06/2011 to 05/2013
Clinical Trials Coordinator Glaukos Burlington, MA,

Duties:

  • Managed and maintained Trial Master Files for OGX study products      
  • Managed Drug Safety case processing and developed CIOMS and MedWatch reports for submission to regulatory authorities and distribution to CROs       
  • Oversaw, managed and presented at 2 domestic and 4 international Investigator Meetings for phase II/III global clinical trials
  • Managed country-specific and site-specific informed consent form development during the study start-up process for global phase II/III clinical trials
  • Assisted in review of study documentation (e.g. protocol amendments, consent form template, pharmacy manual, study management plan, etc.)
  • Managed initial site shipments of drug working closely with drug distribution vendor
  • Assisted with quality checks of clinical database (e.g. Merge) during study start up

Key Accomplishments:

  • Successfully managed 6 investigator meetings, which were executed on time and on budget
  • Promoted to Drug Safety Associate


10/2010 to 05/2011
Clinical Trials Coordinator Glaukos Boston, MA,

Duties:

  • Developed, managed and maintained clinical study Trial Master Files
  • Assisted with monitoring of clinical research data and the creation of data queries
  • Helped edit and develop Institutional Review Board study submission documentation
  • Created and managed a myriad of regulatory trackers
  • Acted as data documentation coordinator for preclinical studies
  • Conducted QC of study documentation (e.g. clinical study reports, study protocols and supporting documents)
  • Provided general support for Clinical R&D team


2010 to 08/2010
IRB Administrative Review Coordinator, Institutional Review Board, Office of the Vice Chancellor for Research Hoffmann-La Roche Ltd Baltimore, MD,

Duties:

  • Voting board member for the Social/Behavioral/Educational (SBE) Research Panel
  • Alternative coordinator for Biomedical and SBE Research Panel
  • Lead reviewer for all Expedited and Exempt Behavioral/Social/Marketing/Educational human subject research protocols
  • Developed new, and edited existing internal and external guidance documentation to be used by staff, student researchers and faculty
  • Edited and maintained all standard university informed consent form templates for human subject research
  • Assisted with the revision of IRB Standard Operating Procedures (SOPs)
  • Assisted in QA of active research files
  • Educated faculty and student researchers on human subjects research regulations


06/2008 to 2010
Panel A Coordinator, Institutional Review Board, Office of the Vice Chancellor of Research Coda Tigard, OR,

Duties:

  • Voting board member for the Behavioral/Social/Educational Panel and alternative voting member for the Biomedical Panel
  • Responsible for the review of all expedited and exempt Panel A protocols
  • Assisted in refining the IRB’s current Standard Operating Procedures
  • Coordinated Full Board meetings and transcribed the monthly meeting minutes
  • Processed all approval documentation and research communication associated with Panel A protocols

Key Accomplishments:

Overhauled the review process and improved the review turnaround time from 6 weeks to 24-48 hours for all expedited and exempt research protocols

Promoted into IRB Administrative Review Coordinator



06/2007 to 05/2008
Study Manager Quorum Review, Institutional Review Board City, STATE,

Duties:

  • Oversaw research studies (Phases II-IV), acting as the liaison between the sponsor and the IRB
  • Provided continual support to the sponsoring pharmaceutical company and/or contract research organization (CRO) throughout the duration of a research study
  •  Analyzed and prepared all sponsor submitted study materials for Board review
  • Aided and educated sponsoring pharmaceutical companies/CROs and investigational research sites on the policies and procedures instituted by the IRB
  • Maintainence of study files
  • Resolved complex study matters and ensured regulatory compliance with FDA regulations
  • Worked and collaborated with numerous internal departments to make certain all matters involving the studies and their sites are cared for at the time of inquiry

Key Accomplishments:

Acted as the dedicated Study Manager for Quorum Review’s largest client and was acknowledged as being responsible for the fastest study start-up in the client’s history


2007 to 06/2007
Site Support Specialist Quorum Review, Institutional Review Board City, STATE,

Duties:

  • Prepared initial site documentation for Board review
  • Assisted investigational research sites with questions and concerns with regards to initial site specific submissions
  • Provided study coordinators and principal investigators with guidance about possible protocol deviations or serious adverse event reporting

Education
Expected in 2005
Bachelor of Arts:
University of Washington - Seattle,
GPA:
Courses completed in chemistry, nutrition, psychology, anatomy and medical terminology.
Certifications

Course Certificates:

  • Bacteria and Chronic Infections, University of Copenhagen (via Coursera.org)
  • Design and Interpretation of Clinical Trials, Johns Hopkins University (via Coursera.org)
  • Introduction to the Biology of Cancer, Johns Hopkins University (via Coursera.org)
Additional Information
LinkedIn URL: https://www.linkedin.com/in/JessicaClaire

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Resume Overview

School Attended

  • University of Washington

Job Titles Held:

  • Senior Drug Safety Associate
  • Drug Safety Associate
  • Clinical Trials Coordinator
  • Clinical Trials Coordinator
  • IRB Administrative Review Coordinator, Institutional Review Board, Office of the Vice Chancellor for Research
  • Panel A Coordinator, Institutional Review Board, Office of the Vice Chancellor of Research
  • Study Manager
  • Site Support Specialist

Degrees

  • Bachelor of Arts

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