Joanna Bernstein
Hillsborough,New Jersey
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Seeking a position in clinical project management that offers overseeing clinical trials and/or development of clinical project managers.
Overview
32
32
years of professional experience
1
1
Certification
Work History
Director, Xcellerate Customer Success
Fortrea Inc.
04.2013 - Current
- Xcellerate Customer Success Lead to establish a clear understanding of key business processes including clarity over process inputs, outputs and relationships as it relates to a specific product (ex
- Electronic Trial Master File, Clinical Trial Management System, Xcellerate Portal, Xcellerate Study Dashboard, Xcellerate CRA Dashboard, Xcellerate Portfolio Dashboard, Project Delivery Hub and the User Provisioning System)
- Implement vision and direction by providing leadership, training, direction, and change management for technology solutions to allow operations to effectively and efficiently manage the planning and execution of clinical programs for a specific product
- Build quality into applications and associated business process, look for improvement opportunities and translate improvement opportunities into realities to define the product strategy and roadmap
- Work with operations in order to revise applications and associated business processes, designing quality and controls into the application and/or process and ensure a mechanism for measuring metrics
- Engage key stakeholders around shared objectives for associated business process design and execution, including consequence management and to conduct training and lead awareness efforts to promote and educate
- Contribute to all relevant policies and standard operating procedures (SOPs)
- Contact for both internal staff and sponsors for matters pertaining to products
- Work with external third parties as necessary in the execution of the product strategy and vision
- Partner with Marketing to ensure a proper, consistent message is being delivered
- Frequently assist Business Development and clinical teams with proposals and bid defenses
- Understanding and adherence to IT System Life Cycle processes
- Quality Tolerance Limits (QTLs) subject matter expert
- Mentoring and line management of Xcellerate Managers
Project Director, Oncology, Early Clinical Development
Fortrea Inc.
03.2011 - 04.2013
- Responsible for on time, on-budget provision of client deliverables for assigned projects and programs
- Contract review/negotiation, study budget management for overall revenues of $1-5M annually per study and lead project review meetings
- Project specific training including the development of project plans and CRF completion guidelines and management of the core project team with assurance to adhere to professional standards and SOPs and facilitate team’s ability to lead extended/complete project team
- Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects or programs
- Monitor team performance and facilitate adjustments when necessary to ensure goal attainment and management of project resource needs and establish contingency plans for key resources
- Prepare, lead and follow-up on study and program management team meetings, kick-off meetings, face-to-face meetings, dose-escalation and Data Monitoring Committee (DMC) meetings
- Responsible for appropriate issue escalation to the Corrective Action Issue Resolution program and/or stakeholders
- Establish working relationships with client project teams and vendors (Electronic Data Capture (EDC), central imaging, central electrocardiogram (ECG), Interactive Voice/Web Response Systems (IXRS), electronic questionnaires and Site Management Office (SMO), central laboratories) which result in client satisfaction, operational excellence and thereby increase potential for repeat client business
- Prepare and present proposals for new business in collaboration with business development
- Mentoring and line management of Project Managers
Senior Project Manager
Fortrea Inc.
04.2009 - 03.2011
- Manage Phase I, II, III Oncology Trials
- Responsible for on time, on-budget provision of client deliverables for assigned projects
- Contract review/negotiation, study budget management for overall revenues of $3.5-5M annually and lead project review meetings
- Project specific training and management of the project team
- Prepare, lead and follow-up on study management team meetings, CRA teleconferences, dose-escalation and DMC meetings
- Develop project plans and CRF completion guidelines
- Interact on a regular basis with Regulatory, Data Management, Programming, Statistics, Medical Writing
- Vendor (EDC, central imaging, central ECG, IXRS, electronic questionnaires) and SMO management
Project Manager
Fortrea Inc.
09.2006 - 04.2009
- Manage Phase I, II, III Oncology Trials
- Responsible for study progress tracking, adherence to timelines, resource management and monitoring
- Managed study budget and led project review meetings
- Project specific training and management of the project team
- Prepared, led and followed up on study management team meetings and CRA teleconferences
- Developed project plans and CRF completion guidelines
- Interacted on a regular basis with Data Management to ensure consistency between monitoring and data management expectations
- Vendor, SMO and Line management
Senior Clinical Research Associate/Acting Project Manager
Fortrea Inc.
09.2005 - 09.2006
- Assisted the Project Director with review and management of the Estimated Value Analysis and billable time review
- Presented at Clinical Research Associate (CRA) and Clinical Research Coordinator training meetings, performed training of Princeton based and regional CRAs in all aspects of monitoring visits and transitioning onto new protocols, and conducted Accompanied Field Visit evaluations for new hire and contract CRAs
- Primary contact for the field CRAs for protocol, Case Report Form (CRF) review/retrieval assignments and Trial Tracker related issues
- Maintained and developed tracking spreadsheets for Sponsor updates of Protocol Exceptions, CRFs reviewed/collected and monitoring calendars
- Created monitoring tools to ensure efficiency in the field
- Assisted Covance Data Management with the implementation of data checks
- Created and validated trip reporting modules in Trial Tracker
- Responsible for monitoring clinical trials within an assigned geographic region, and prepared, reviewed and approved accurate and timely trip reports
Regional Clinical Research Associate
Aris Clinical, Inc.
06.2004 - 09.2005
- Provided site management for multi-center clinical trials in various therapeutic areas
- Conducted site qualification, initiation, monitoring, and closeout visits (80% travel)
- Conducted site quality assurance audits for Sponsor companies
- Prepared accurate and timely trip reports
- Interviewed Clinical Research Associate candidates
Contract Country Clinical Operations Associate
Kforce Pharmaceutical Staffing-Hoffmann-La Roche Inc
07.2003 - 06.2004
- Provided accurate and timely support to monitors within the US to ensure consistent study conduct
- Direct contact with Clinical Science team to provide appropriate feedback to the sites and monitors
- Provided direction and mentoring to other Clinical Operations Associates and support staff specifically dealing with US regulatory concerns according to ICH guidelines and Roche SOPs
- Reviewed, approved and tracked the contents of the US regulatory file of ICH essential documents, and the management of the flow of required documents to the appropriate archives, and regularly liaise with archive staff
- Assisted the Country Study Manager (CSM) in determining US drug inventory requirement and manage local drug ordering, shipping, packing, destruction/return and tracking
- Oversaw the management of tracking systems for the study team related to drug supply and use, enrollment of subjects, regulatory document flow, study timelines, financial information, Serious Adverse Events and MonWeb
- Developed and distributed safety updates, general correspondence, investigator/patient tools and study newsletters to US monitors and sites
- Managed the processing of SAE information received from investigators including review, clarification, tracking and interactions with monitors, sites, and Clinical Science
Clinical Research Associate II
Covance Inc.
09.2002 - 07.2003
- Assisted with the administration of clinical research projects: recruiting Investigators, collecting Investigator documentation according to International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and preparing monthly status reports
- Responsible for all aspects of study site management including the maintenance of study files, pre-study and initiation visits, routine monitoring of source documentation and CRFs for missing or implausible data, closeout of clinical sites and when warranted site rescue visits (60% travel), follow-up on serious adverse events and generate and track drug shipments and storage
- Assisted and managed project budget and Investigator site budget, assisted legal department with Investigator agreements, led project team meetings, planned and attended Investigator meetings, and communicated with clients
- Trained CRAs in all aspects of monitoring visits and transitioning onto new protocols
- Liaised with Sponsors and central laboratories including central radiology and ECG
Clinical Research Associate I
Covance Inc.
01.2001 - 09.2002
- Assisted with the administration of clinical research projects: recruiting Investigators, collecting Investigator documentation according to ICH and GCP guidelines and monthly status reports
- Responsible for all aspects of study site management including the maintenance of study files, pre-study and initiation visits, routine monitoring of source documentation and CRFs for missing or implausible data, and closeout of clinical sites (50% travel), follow-up on serious adverse events and generate and track drug shipments and storage
- Prepared accurate and timely trip reports, confirmation and follow-up letters
Clinical Research Assistant
Covance Inc.
09.2000 - 01.2001
- Assisted with the administration of clinical research projects: recruiting Investigators, collecting Investigator documentation according to ICH and GCP guidelines and preparing status reports
- Assisted with study site management including the maintenance of study files, pre-study and initiation visits, routine monitoring of source documentation and CRFs for missing or implausible data, and closeout of clinical sites (40% travel), follow-up on serious adverse events and generate and track drug shipments and storage
- Prepared accurate and timely trip reports, confirmation and follow-up letters
Senior Research Associate, Biology Department
Palatin Technologies, Inc.
01.1998 - 02.2000
- Responsible for evaluating novel small peptides and preclinical drugs through the disciplines of molecular biology, histology, biochemistry, cell biology, and in vivo techniques
- Preclinical therapeutic areas include inflammation imaging, tumor imaging and erectile dysfunction
Medical/Research Technologist, Mycology and Molecular Tissue Pathology Department
Quest Diagnostics, Inc.
10.1992 - 01.1998
- Cultivation and identification of filamentous fungi, yeasts and actinomycetes
- Responsible for the immunodetection of antigens and nucleic acid hybridization on paraffin embedded tissue, fresh frozen tissue, and body fluids for the diagnosis of cancer and viral diseases
- Test validation and research performed to develop new diagnostic assays and to increase the sensitivity of existing methods
Education
Masters of Science - Biology
Fairleigh Dickinson University
Teaneck, New JerseyBachelors of Science - Biology (concentration in Biotechnology)
Fairleigh Dickinson University
Teaneck, New JerseySkills
Mentor
Patents
- Compositions and methods for treatment of sexual dysfunction 6794489
- Compositions and methods for treatment of sexual dysfunction 6579968
Membershipsawards
Covance Way Award - 2014
Certification
Certified Project Manager
Timeline
Director, Xcellerate Customer Success
Fortrea Inc.
04.2013 - Current
Project Director, Oncology, Early Clinical Development
Fortrea Inc.
03.2011 - 04.2013
Senior Project Manager
Fortrea Inc.
04.2009 - 03.2011
Project Manager
Fortrea Inc.
09.2006 - 04.2009
Senior Clinical Research Associate/Acting Project Manager
Fortrea Inc.
09.2005 - 09.2006
Regional Clinical Research Associate
Aris Clinical, Inc.
06.2004 - 09.2005
Contract Country Clinical Operations Associate
Kforce Pharmaceutical Staffing-Hoffmann-La Roche Inc
07.2003 - 06.2004
Clinical Research Associate II
Covance Inc.
09.2002 - 07.2003
Clinical Research Associate I
Covance Inc.
01.2001 - 09.2002
Clinical Research Assistant
Covance Inc.
09.2000 - 01.2001
Senior Research Associate, Biology Department
Palatin Technologies, Inc.
01.1998 - 02.2000
Medical/Research Technologist, Mycology and Molecular Tissue Pathology Department
Quest Diagnostics, Inc.
10.1992 - 01.1998
Masters of Science - Biology
Fairleigh Dickinson University
Bachelors of Science - Biology (concentration in Biotechnology)
Fairleigh Dickinson University