Breanna Williams
Canoga Park
Summary
Accomplished Project Coordinator with a proven track record at Novartis Pharmaceuticals, adept in enhancing team collaboration and improving project delivery timelines. Expert in project management and critical thinking, I significantly contributed to advancing clinical research outcomes. Demonstrated excellence in regulatory compliance and patient safety, ensuring project success without compromising detail or accuracy.
Overview
6
6
years of professional experience
Work History
Project Coordinator
Novartis Pharmaceuticals
12.2020 - 02.2024
- Kept projects on schedule by managing deadlines and adjusting workflows.
- Supervised multiple projects from project start through delivery by prioritizing needs and delegating assignments.
- Enhanced team collaboration through regular meetings, fostering a positive work environment for increased productivity.
- Liaised between departments to facilitate communication and keep appropriate parties updated on project developments.
- Monitor and update project deliverables including specimen shipments and clinical trial testing.
- Independently coordinate studies, including screening potential patients for protocol eligibility, explaining trial concepts, and participating in the informed consent process.
- Schedule research visits and procedures for patients participating in studies.
- Collaborate with physicians and medical staff to thoroughly document patient information, including changes in condition, adverse events, and medication use, on Case Report Forms (CRFs).
- Ensure accurate and timely data collection, documentation, entry, and reporting, including responding promptly to sponsor queries.
- Compile and report study information, including protocol activity, accrual data, and workload, and present findings at regular research staff meetings. Notify supervisors of concerns regarding data quality and study conduct.
- Work closely with regulatory coordinators or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with guidelines.
- Perform additional regulatory/IRB duties, budgeting tasks, and assist with patient research billing and reconciliation as needed.
Associate Clinical Research Specialist
Medtronic
07.2018 - 11.2019
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Advanced scientific understanding by authoring manuscripts detailing study findings for publication in peer-reviewed journals.
- Maximized operational efficiency by developing and maintaining SOPs for various aspects of the clinical research process.
- Assisted principal investigators in preparing grant proposals, securing funding for critical research projects.
- Coordinate in-house feasibility studies in order to gain data for the development of Medtronic diabetes devices and products.
- Independently coordinate studies, including screening potential patients for protocol eligibility, explaining trial concepts, and participating in the informed consent process. Schedule research visits and procedures for patients participating in studies.
- Collaborate with physicians and medical staff to thoroughly document patient information, including changes in condition, adverse events, and medication use, on Case Report Forms (CRFs).
- Ensure accurate and timely data collection, documentation, entry, and reporting, including responding promptly to sponsor queries.
- Compile and report study information, including protocol activity, accrual data, and workload, and present findings at regular research staff meetings.
- Notify supervisors of concerns regarding data quality and study conduct.
- Work closely with regulatory coordinators or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with guidelines.
- Perform additional regulatory/IRB duties, budgeting tasks, and assist with patient research billing and reconciliation as needed.
- Ensure compliance with federal and local agencies, including the FDA and local IRB, maintaining adherence to Good Clinical Practice (GCP) guidelines.
- Maintain strict patient confidentiality in accordance with HIPAA regulations and applicable laws.
- Conduct all study activities and procedures including, recruiting and consenting subjects, inserting and removing subcutaneous glucose sensors, performing skin assessments, training on device usage, collecting date and entering it into Oracle RDC and maintain study inventory.
- Support the implementation of physician-initiated studies.
Education
Bachelor of Arts - Communication Studies
California State University, Northridge
Northridge, CA05-2018
Skills
- Problem-solving
- Project coordination
- Time management
- Detail-oriented
- Critical thinking
- Flexible and adaptable
- Project management
Timeline
Project Coordinator
Novartis Pharmaceuticals
12.2020 - 02.2024
Associate Clinical Research Specialist
Medtronic
07.2018 - 11.2019
Bachelor of Arts - Communication Studies
California State University, Northridge
Similar Profiles
Ananya K UAnanya K U
Statistical Programming Intern at Novartis PharmaceuticalsStatistical Programming Intern at Novartis Pharmaceuticals
Jacqueline B. Palmer-OuchakovJacqueline B. Palmer-Ouchakov
Product Strategy – General Management Rotation, Immunology at Novartis PharmaceuticalsProduct Strategy – General Management Rotation, Immunology at Novartis Pharmaceuticals
Teresa AndersonTeresa Anderson
Patient Navigator Radioligand Therapy at Novartis PharmaceuticalsPatient Navigator Radioligand Therapy at Novartis Pharmaceuticals
Kirstie KeelKirstie Keel
Senior Territory Account Specialist at Novartis PharmaceuticalsSenior Territory Account Specialist at Novartis Pharmaceuticals
Melissa PeckMelissa Peck
General Manager at Extended Stay AmericaGeneral Manager at Extended Stay America