Elizabeth O'Connor Email & Phone Number

Manhattan Beach, California, United States

• Precision Promise is an innovative adaptive clinical trial platform designed to accelerate the development of new treatments for pancreatic cancer. With a primary endpoint of overall survival that can include multiple.
• Responsible for alliance management of arm sponsors (e.g., pharmaceutical companies) interested in their investigational drug being studied on the Precision Promise (PrP) platform.
• Engage with PanCAN stakeholders and committees who are contributing to the design of PrP.
• Lead efforts to ensure that CRO operational plans and budgets support each new treatment arm’s activation and downstream deliverables.
• Develop sponsor SOPs that define clinical operations, drug safety, GMP, and QA processes for overseeing the management and administration of investigational products.
• Author or perform clinical science reviews of clinical protocols, data collection and management plans, site training documents, safety narratives, patient profiles, and clinical study reports.

Oakland, California, United States

• Served as credentialed Principal Investigator/Program Director for the Children’s Oncology Group Coordinating Center (COGCC) program at the Public Health Institute, providing vision and strategic direction.
• Provided oversight of recruitment, supervision, and performance management for 100+ staff within the COGCC program.
• Assured and held program staff accountable for ethical, legal, and scientific integrity in all program activities, including knowledge of and adherence to all federal and state laws.
• Developed budgets and SOWs for funders. Monitored and met all post-award reporting requirements and ensured progress reports were completed on time.
• Reviewed finance reports and adjusted budgets accordingly.

Monrovia, California, United States

• Led clinical research, data operations, and administration for the Children’s Oncology Group (COG), a National Cancer Institute (NCI)-funded National Clinical Trials Network (NCTN) group and NCI Community Oncology.
• Provided organizational direction of central operations, including supervising department directors. Allocated resources and personnel to support 220+ children’s hospitals and academic research institutions enrolling.
• Engaged with scientific leadership to inform strategic planning for operational infrastructure and ensure it addressed the evolving complexities of COG’s trial portfolio.
• Guided enhancements to information technology infrastructure and data capture systems in support of COG’s expanding scope of research (e.g., precision medicine, patient-reported outcomes (PROs), and health economics &.
• Negotiated contracts and budgets with pharmaceutical industry partners, including evaluating, selecting, and managing CROs, central laboratories, and other clinical study vendors.
• Authored grants and budget proposals awarded to the broader research program.

Arcadia, California, United States

• Directed operations of a 21-institution NCI-funded pediatric oncology early-phase drug development network that served to study the safety of investigational new drugs expeditiously.
• Defined and implemented processes and infrastructure to conduct developmental therapeutic clinical trials that collect safety and pharmacokinetic data to determine optimal dosing.
• Trained and managed a multi-disciplinary team comprising protocol writers, study builders, data managers, and statisticians who supported the unique demands of early-phase clinical trials.
• Filed and maintained all group-held investigational new drug (IND) applications with the FDA and served as the contact for operational issues during the conduct of industry-sponsored trials.

Arcadia, California, United States

• Co-wrote phase 1, 2, and 3 clinical trial protocols with pediatric oncologists, designed treatment roadmaps, and wrote sample informed consent documents and site training materials.
• Managed submissions to and drafted responses for all required reviews and regulatory approvals of new studies and amendments. Authored all site communications for ongoing trials.

Los Angeles, California, United States

• Neurosurgery, Official Journal of the Congress of Neurological Surgeons
• Verified requisite composition of submitted scientific manuscripts for international medical journal and summarized peer reviews for use by editor in making acceptance decisions.

Boston, Massachusetts, United States

• Secured resources for patients with needs not met by the hospital and facilitated discharge plans for patients requiring skilled nursing home or rehabilitation hospital placement.

Master Of Public Health - Mph

Bachelor Of Arts - Ba, English