JULIE STERNBERG
Stevenson Ranch,CA
Summary
Possesses versatile skills in project management, problem-solving, and collaboration. Brings fresh perspective and strong commitment to quality and success. Recognized for adaptability and proactive approach in delivering effective solutions. Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Skilled Researcher enthusiastic about supporting advancements in Oncology and Endocrinology. Passionate about increasing knowledge to drive growth and needed improvements. Ready to apply knowledge and 30 years of experience in research.
Innovative Researcher adept at developing probing questions, designing experiments and generating meaningful results. Experienced at identifying and using new technologies and resources. Works effectively and collaboratively with teams and individuals.
Knowledgeable Research Associate with robust background in conducting and analyzing scientific studies. Contributed to significant research projects and collaborated with cross-functional teams to drive innovative solutions. Demonstrated critical thinking and proficiency in data analysis and research methodologies.
Professional researcher with passion for advancing scientific knowledge. Proven track record in designing and executing research experiments, contributing to published studies. Known for strong team collaboration and adaptability, with key skills in data collection and statistical analysis.
Overview
13
13
years of professional experience
Work History
CLINICAL TRIALS REGULATORY RESEARCH ASSOCIATE
University of California San Diego – Moores Cancer Center
01.2024 - 06.2024
- Supported the Regulatory Department at UCSD Moores Cancer Center and their clinical research teams with IRB submissions and maintenance documentation for the Head and Neck Cancer team and the Neurology Cancer team.
- Acted as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, IRB, and the Clinical Trial Office
- Prepared clinical research protocols and related regulatory documents for submission to the Human Research Protection Program (IRB)
- Summarized sources of data and information, and reviewed the data and information obtained to create documents
- Maintained working knowledge of the policies and procedures of the IRB and of the VA Human Subjects Office; reviewed these policies and procedures under the general supervision of the Medical Director of Regulatory Affairs
- Maintained working knowledge of the policies, procedures and regulations of the FDA and the National Cancer Institute pertaining to adverse event reporting and the informed consent of human subjects
- Reviewed, analyzed and interpreted sponsors clinical research protocol and Investigator Brochure and abstract key information from these documents in order to assist with preparing Research Plan application in format required for IRB submission
- Prepared Investigational Drug Fact Sheets using sponsors protocol, Investigator Brochure, and pharmaceutical literature as needed
- Created Informed Consent Documents for human subjects in a manner that complies with IRB policies and procedures, FDA regulations covering consent of human subjects, and sponsors requirements; edited as needed to make changes that satisfy the IRB, sponsor, and investigator
- Composed wording to describe in language understandable to a layperson the study procedures and treatments, including risks of the study drug
- Prepared and submited protocol amendments to the IRB, including modifications to the Research Plan and Informed Consent Document notating key changes to the protocols
- Submitted to the Cancer Centers Protocol Review and Monitoring Committee PRMC for review as needed; submitted Investigator Brochures and IND Safety Reports to the IRB, summarizing key changes
- Prepared annual reports on the progress of the trial
- Determined source of data and information to create the report including sponsor, investigator, clinical research project manager and coordinators, and adverse event reports, and summarize the information in order to submit the reports
- Developed responses to IRB questions and stipulations in order to obtain approval of the trial by finding sources of data and information needed to answer the questions and to resolve issues and composing responses
- Maintained the regulatory files for the clinical trials office’s clinical trials in accordance with their policies and procedures
- Prepared files for monitoring visits and internal external audits, including those by the Cancer Center CTO, Cancer Center DSMB, VA Compliance Office, commercial sponsors, National Cancer Institute, and its cooperative groups
- Maintained a large database, tracking protocol information, including IRB and Cancer Center review process
- Developed and produced protocol status reports, as needed
- Independently coordinated and was accountable for the overall administration and outcome of one or more clinical studies, typically requiring advanced level knowledge and skills
- Responsible for the complex function of the regulatory program within the CTO
- Coordinated and managed all regulatory activities and resources to ensure timely execution of tasks
- Interacted with a variety of internal and external contacts including Cancer Center investigators and staff Office of IRB Administration staff VA Human Subjects Protections staff Clinical Trials Administrative Services staff, division department heads federal, state and nonprofit agencies corporate sponsors of research and contract research organizations
- Liaised with Principal Investigator and key Personnel associated with the projects to initial and review timelines, resolve delays, concerns, and provide detailed updates
- Worked closely and collaboratively with clinical project management staff to plan and delegate collaborative tasks for study coordinators and regulatory associates to ensure completion of research projects in an efficient manner
- Critically evaluated and contributed original ideas on methodological, technical, and theoretical aspects of the procedures and concerns
- Developed, implemented, and updated procedural and training
- Developed and implemented guidelines for maintenance of all regulatory documents
- Responsible for the definition and execution of procedures to assure research and other activities subject to regulatory review are being conducted in accordance with internal, national and international standards and guidelines
- Responsible for training of activities relating to study implementation, regulatory issues, quality management and data entry
- Trained new staff in all areas of IRB submissions and FDA compliance procedures
- Responsible for the definition and execution of procedures to assure research and other activities subject to regulatory review are being conducted in accordance with internal, national and international standards and guidelines
- Collaborated and communicated with the Administrator and Deputy Director of the Clinical Trials Office (CTO) to ensure all parties are informed of any potential problems within the affiliate structure and/or procedures and make recommendations as needed
- Prepared and filed IND applications or IND exemptions to the FDA on behalf of the clinical investigators
- Prepared and filed IDE to the FDA on behalf of cancer center investigators
- Responsible for ensuring the clinical research trials are entered into the ClinicalTrials.Gov database in compliance with recent regulatory requirements
- Analyzed and summarized sources of data and information, and reviewing the protocol, data and information obtained to create documents
- Extensive knowledge of FDA CFR and the National Cancer Institute pertaining to filing NDA applications and serious adverse event reporting
- Designed and prepared Investigational Drug Fact Sheets using the sponsor’s protocol, Investigator Brochure, and pharmaceutical literature as needed.
Regulatory Information Management System Manager
Halozyme Therapeutics, Inc - 16 Month Contract
San Diego, California
08.2022 - 12.2023
- Supported the Regulatory Department at Halozyme Therapeutic, Inc and their clinical research teams with FDA filings and archival processes
- Integrated Veeva Vault as the archiving tool to house all submission and FDA correspondence
- Provided support in development and implementation of global regulatory CMC strategies for Partners' marketed and development products
- Lead and supported regulatory activities for internal and external programs and worked closely with cross-functional subject matter experts to ensure effective partnerships and execution of regulatory strategies, regulatory requirements, and timely submissions and approvals of global regulatory filings
- Contributed to clinical discussions and reviews of documents to support clinical investigations by Partners
- Coordinated and reviewed regulatory submission documents and development activities to support regulatory filings
- Worked with internal, external and vendor resources to manage global regulatory activities
- Interpreted regulations and provided well-reasoned regulatory guidance to cross functional project teams
- Supported and lead the preparation of health authority meeting materials and lead responses to requests for information and responses to FDA driven questions
- Supported management with development and implementation of working procedures, standard operating procedures, and policies
- Researched, prepared, and presented on global regulatory topics to internal and external stakeholders
- Assured compliance with all applicable (domestic and international) regulations including regulatory change management
- Monitored industry and regulatory trends to provide guidance related to such trends to regulatory and cross functional teams
- Compiled and maintained regulatory files and trackers for regulatory information and submission preparation
- Evaluated change requests, provided global Regulatory assessment and coordinated associated submissions
- Researched and compiled CMC portions of regulatory dossiers (Module 1, Module 2 and Module 3)
- Worked cross functionally in a matrix type environment, working with multiple parties such as quality process, development, and stake holders
- Managed successful migration of company data to a new platform, ensuring seamless integration and minimal disruption.
- Wrote and updated technical documentation covering system components.
- Maintained up-to-date knowledge of industry trends and emerging technologies, applying insights to drive continuous improvement initiatives within the organization.
- Conducted thorough audits of existing systems, identifying areas for improvement and implementing strategic updates accordingly.
- Provided technical support and guidance to users, fostering a strong customer-centric culture within the organization.
CLINICAL RESEARCH REGULATORY COORDINATOR
Hoag Memorial Hospital - 8 Month Contract
Newport Beach, California
01.2022 - 08.2022
- Supported the clinical research teams (physicians, nurses, coordinators and regulatory team) at Hoag Memorial Hospital Presbyterian with their research efforts by facilitating the study start-up and approval processes for over 150 new studies
- Maintained documentation of regulatory compliance throughout the trial's duration and close-out for research studies involving human subjects
- Monitored and ensured that all research studies were compliant with GCP, regulations, local and international law
- Maintained accurate and up-to-date regulatory files, in binders and electronic format
- Served as a central source for staff conducting clinical research for the department
- Informed Consent Form writing and redlining of new protocols and amendments
- Trial Master File (TMF) ownership and maintenance
- Performed audits of regulatory documents and spot audits for regulatory compliance in over 250+ active studies
- Served as a liaison between various departments within the organization, promoting understanding of each group''s role in maintaining compliance.
- Improved regulatory compliance by thoroughly reviewing and analyzing company policies and procedures.
- Assisted in the preparation of regulatory documents, supporting successful product launches and expansions into new markets.
- Monitored industry trends and changes in regulations, keeping the company up-to-date with relevant information.
- Conducted internal audits to identify areas of improvement and ensured corrective actions were implemented.
- Coordinated responses to regulatory inquiries, demonstrating the company''s commitment to transparency and adherence to guidelines.
- Streamlined communication between departments for enhanced efficiency in addressing regulatory issues.
- Facilitated process improvements through regular analysis of existing workflows related to regulatory coordination tasks.
- Collaborated with cross-functional teams to develop risk management strategies, mitigating potential compliance concerns.
- Established relationships with key regulators, fostering positive rapport and open lines of communication.
- Managed regulatory submissions, ensuring timely and accurate information was provided to authorities.
- Maintained a strong working knowledge of current regulations, providing expert guidance to colleagues and stakeholders.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Prepared and maintained document inventory for core dossier preparation.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Provided responses to regulatory agencies regarding product information or issues.
- Analyzed field studies and reports, compiled information and submitted concise and informative summaries.
- Devised and deployed techniques for obtaining earliest possible approval for each product.
- Directed documentation efforts to comply with domestic and international regulations and standards.
LEAD SENIOR DATA MANAGER
Montana Cancer Consortium - 8 Month Contract
Billings, Montana
01.2020 - 08.2020
- Performed all aspects of data management and auditing
- Collected source documentation and medical records for clinical trial participants
- Entered pertinent data into the sponsor's Case Report Forms (CRFs)
- Created and maintained patient research records for all clinical trials
- Assisted study coordinators with administrative oversight and the process organization of study participants
- 3-month contract position for Montana Cancer Consortium
- Led the evaluation, selection, and implementation of cutting-edge tools for improved database management and analysis capabilities.
- Collaborated with cross-functional teams to integrate disparate data sources, providing a unified view for analysis purposes.
- Optimized storage solutions through capacity planning exercises, reducing overhead costs while accommodating future growth needs.
- Enabled better decision-making through the development of comprehensive data reports and visualizations.
- Championed innovations in data processing techniques to drive improvements in scalability, speed, and cost efficiency.
- Managed large-scale data migration projects, ensuring seamless transitions with minimal downtime or disruptions.
- Streamlined data management workflows for increased efficiency and faster project completion.
- Improved data accuracy by implementing rigorous quality control measures and data validation processes.
- Played an integral role in the successful delivery of multiple projects, showcasing exceptional multitasking abilities within a fast-paced work environment.
- Wrote and maintained technical and functional specifications to document database intentions and requirements.
SENIOR CLINICAL TRIAL LEAD
Medtronic Inc - 12 Month Contract
Northridge, California
01.2015 - 12.2015
- Wrote clinical protocols, amendments, Informed Consent Forms, study guides, case report forms and patient facing materials
- Negotiated and managed budgets including payments for investigative sites
- Planned and tracked all assigned clinical activity from study start-up to completion
- Identified, selected, and monitored the performance of investigational sites
- Ensured studies were carried out according to the study protocol, SOPs, ICH/GCP regulations and study specific manuals
- Tracked and reported the progress of studies including site activation, patient enrollment, monitoring visits and regulatory submissions
- Reviewed key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determined appropriate action with the study team
- Created and maintained clinical project documents and plans (i.e., Visit Report and Letters
- Designed templates, Monitoring Plans, Project Plans, Communication Plans, Recruitment Plans, etc.
- Developed, conducted and tracked study team members training
- Set-up clinical trial monitoring systems and study tools (study trackers for training, protocol deviations, monitoring visits, reports, letters, etc.)
- Tracked performance metrics for the study team (i.e., training, study visits, report and follow-up letter submission, and monitoring)
- Reviewed and tracked enrollment and data entry timelines for sites
- Worked directly with data management to monitor site accrual and data retrieval
- Identified and assisted project teams with resolution of site-specific issues
- Performed various trial activities including generation of source document worksheets and other tools, oversight of trial enrollment, tracking serious adverse events, protocol deviations and violations, and addressing site questions
- Created a variety of reports, documents, training tools, and correspondence to assist participating trial sites, for internal purposes, in the monitoring and evaluation of the projects progress
- Communicated and escalated unresolved issues at the appropriate time and to the appropriate level of management
- Provided regular site-specific clinical status information to team members and project management and initiated improvements to enhance the efficiency and quality of the work performed on assigned projects
Senior Clinical Research Coordinator
DaVita/HealthCare Partners
Pasadena, California
01.2014 - 01.2015
- Responsible for the management and oversight of clinical research teams (coordinators and research assistants) and provided direction and supervision for the project teams
- Oversaw multiple clinical research studies and sites to align clinics, investigators and research teams to deliver successful clinical trials
- Ensured effective integration of studies into care operations
- Established and ensured delivery of budgets and contracts, recruitment, enrollment, retention, and start-up goals
- Ensured contract deliverables were achieved on time and according to budget
- Promoted good clinical practices in the conduct of clinical trials and assured compliance with protocol and regulatory requirements
- Exhibited behavior and communication skills that demonstrated HealthCare Partners' (HCP) commitment to superior customer service, including quality, care and concern with each internal and external customer
- Maintained project portfolio, established and aligned performance to targets
- Provided direction and oversight for clinical trials to ensure studies were conducted according to regulations and expectations
- Ensured project delivery to contractual and customer expectations; ensured excellence in service delivery
- Supported the delivery of the quality management plan, regulatory plan and contracts with individual sponsors
- Managed investigational product (IP) accountability forms and the reconciliation processes
- Ensured timely submission of data required for revenue recognition, invoicing and other expense reporting techniques.
- Implemented quality control measures across all areas of the study process to ensure accurate, reliable data collection and analysis.
- Facilitated clinical trial progression, effectively managing multiple projects simultaneously.
- Collaborated with investigators to develop innovative clinical trial designs, optimizing data collection methods for better results.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Complied with research protocols by providing ongoing quality control audits.
Senior Regulatory Project Coordinator
AMGEN, Inc. - 18 Month Contract
Thousand Oaks, California
09.2011 - 01.2013
- Supported the compilation, submission and archiving of regulatory dossiers, maintenance of core dossier components, and documentation associated submissions
- Maintained the regulatory document management systems and tracking systems
- Performed quality control audits of regulatory dossiers, archiving systems and tracking systems within the Trial Master Files (TMF)
- Acted as the primary regulatory operations point of contact between clinical, manufacturing, global regulatory and publishing teams, while streamlining and implementing processes to improve the regulatory process
- Maintained the EPIC dictionary, team SharePoint sites and associated documentation
- Responsible for the electronic document management of ongoing submissions
- Performed regulatory archiving activities, quality control, information requests and metrics generation
- Liaised with internal and external customers to determine key performance and compliance indicators, liaised with reporting groups to process complaint resolution on complex issues
- Developed standards and templates for routine processes
- Contributed to the development and roll out of training, training documentation and e- manuals
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Maintained accurate documentation of all projects, facilitating efficient audits and future reference.
- Responded to requests for information on materials to inquiring parties.
- Elevated overall quality of completed projects by consistently monitoring progress and addressing issues proactively.
- Ensured prompt resolution of any conflicts or obstacles encountered during the course of a project''s execution phase, helping maintain smooth workflow across departments involved in its completion process.
- Led project documentation efforts, ensuring accurate and timely updates were accessible, significantly reducing information gaps.
- Monitored project progress, identified risks and took corrective action as needed.
Education
Bachelor of Science - Nursing Administration
College of The Canyons
Valencia, CA05.2007
High School Diploma -
Mountain High School
Lake Arrowhead, CA06.1989
Skills
- Submission preparation
- Data Gathering
- Marketing
- Quality Management Systems
- Good Clinical Practices
- Regulatory Submissions
- International Regulations
- FDA regulations
- Biotechnology Regulations
- Regulatory Inspection Readiness
- Electronic Common Technical Document
- Document Management
- Regulatory Strategy
- Trial data handling
- Document Control
- Clinical Trials Protocols
- Project Management
- Regulatory Agency Applications
- Scientific writing
- Literature reviews
- Ethics compliance
- Research and analysis
- Progress reporting
- Technical report writing
- Documentation skills
- Technical writing
- Research planning
- Clinical research
- Protocol development
- Project management
- Participant screening
- Documentation
- Source verification
- Research methodology
- Data extraction
- Participant recruitment
- Critical thinking
- Strong work ethic
- Data collection and organization
- MS office
- Research presentation
- Works Well Under Pressure
- Team collaboration
- Delivering presentations
- Interpreting results
- Best practices
- Progress tracking
- Attention to detail
- File management
- Active listening
- New system implementation
- Driving decision making
Timeline
CLINICAL TRIALS REGULATORY RESEARCH ASSOCIATE
University of California San Diego – Moores Cancer Center
01.2024 - 06.2024
Regulatory Information Management System Manager
Halozyme Therapeutics, Inc - 16 Month Contract
08.2022 - 12.2023
CLINICAL RESEARCH REGULATORY COORDINATOR
Hoag Memorial Hospital - 8 Month Contract
01.2022 - 08.2022
LEAD SENIOR DATA MANAGER
Montana Cancer Consortium - 8 Month Contract
01.2020 - 08.2020
SENIOR CLINICAL TRIAL LEAD
Medtronic Inc - 12 Month Contract
01.2015 - 12.2015
Senior Clinical Research Coordinator
DaVita/HealthCare Partners
01.2014 - 01.2015
Senior Regulatory Project Coordinator
AMGEN, Inc. - 18 Month Contract
09.2011 - 01.2013
Bachelor of Science - Nursing Administration
College of The Canyons
High School Diploma -
Mountain High School
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