Nicoleta Smith

• Collaborated with Global Quality Assurance Team to oversee quality assurance across GenesisCare' Site Research Organization (SRO), Contract Research Organization (CRO) and Sponsor Unit.
• Fulfilled a secondary role as the Global Data Privacy Officer for GenesisCare CRO, ensuring strict global data privacy compliance for clinical trials conducted in key international locations including the US, Australia, UK, and Spain.
• Managed VEEVA Quality Management System (VEEVA QMS), ensuring its alignment with GenesisCare's Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) Guidelines, and a spectrum of national and international regulatory frameworks.
• Monitored quality metrics and managed business improvement initiatives.
• Manage all aspects of the SOP development, document control and approval system, training and implementation.
• Conducted internal audits as part of the Research Quality Plan, and assisted teams in preparation for external sponsor audits and regulatory inspections.
• Employed a hands-on leadership style, fostering a culture of high-quality research, collaboration and operational efficiency.
• My contributions were recognized in GenesisCare Faces of Research: https://www.genesiscare.com/us/specialists/collaborating-together/faces-of-research-and-insights-january-february-edition

• Managed Michigan Radiation Oncology Quality Consortium (MROQC) quality initiative at GenesisCare/MHP Radiation Oncology.
• Supervised and elevated the performance of regional MROQC research staff, ensuring superior data collection and accuracy.
• Acted as an influential liaison among various MROQC research sites, physicians, and staff, fostering effective collaboration and communication.
• Conducted thorough screening of patient records for breast, lung, prostate and bone metastatic cases, determining eligibility for MROQC enrollment.
• Supervised meticulous reporting, monitoring, and auditing processes in line with MROQC standards.
• Engaged actively in MROQC conferences and study groups, sharing insights and gaining knowledge from the field’s leading experts.
• Under my stewardship, the program achieved a landmark success by doubling annual enrollment to MROQC, surpassing 400 participants. This strategic accomplishment not only enhanced the scope and depth of the consortium's research but also led to a substantial increase in the company's revenue and reimbursement.

• Served as a Quality Assurance Coordinator in the Transplant Department of Henry Ford Health System (HFHS), specializing in quality management for heart transplants and Ventricular Assist Device (VAD) implants.
• Provided regulatory guidance and strategic recommendations to staff across various transplant programs, reporting directly to the Director of Quality for Transplant.
• Ensured strict adherence to transplant protocols in compliance with HFHS policies, CMS Transplant Quality Assessment and Performance Improvement (QAPI) Program Guidelines, Joint Commission's (JC) guidelines, and United Network for Organ Sharing (UNOS) regulations.
• Collaborated with Transplant QAPI Committee, to develop and monitor key performance metrics, focusing on addressing performance deficiencies and ensuring patient safety.
• Actively participated in the Morbidity and Mortality (M&M) meetings, contributing to critical discussions focused on improving patient outcomes in transplant procedures. My role involved case analysis and presentation of transplant outcomes, fostering a multidisciplinary dialogue to identify and learn from adverse events and complications. These sessions were instrumental in developing and implementing quality improvement strategies, enhancing the overall standard of care and ensuring adherence to best practices in our transplant program.
• Managed the abstraction and accurate reporting of medical data into the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and the Organ Procurement and Transplantation Network (OPTN) database.

• Responsible for IRB coordination and regulatory maintenance for over 90 clinical trials, in strict adherence to Good Clinical Practice (GCP) Guidelines and the Code of Federal Regulations (CFR).
• Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
• Planned, developed and submitted essential regulatory documents to the Institutional Review Board (IRB), such as new protocol applications, annual renewals, protocol revisions and safety reports.
• Engaged with sponsors, IRB, Principal Investigators, and study teams, ensuring transparent and timely communication of Serious Adverse Events and protocol changes.
• Collaborated closely with other team members to prepare and participate in internal and external audits.

Served dual role as the Operations Manager of the Molecular Epidemiology Research Laboratory (MERL) within the Public Health Sciences Department (PHS) and the Environmental Specimens Core Coordinator for the a major national $75 million project tracking the health of over 100,000 children from pre-birth to age 21.

Operations Manager of MERL:

• Led a diverse research team, encompassing PhD-level, senior, and junior researchers and assistants.
• Employed LEAN methodologies and strategic leadership as a member of the PHS Executive Committee.
• Managed complex study budgets, supply chain, and resource optimization.
• Ensured strict compliance with CLIA, FDA, OSHA, HIPAA and NIH regulations and guidelines.
• Enhanced research productivity and project execution, establishing benchmarks in operational excellence, team development, process improvement and safety adherence.

MANCS Environmental Specimens Core Coordinator

• MANCS was the Michigan segment of the NIH-funded National Children's Study (NCS), a significant $75 million endeavor tracking the health of over 100,000 children nationwide from pre-birth to age 21.
• Facilitated seamless integration of diverse research efforts through my representation of HFHS in collaborations with key MANCS players, including the University of Michigan, Wayne State University, and the Karmanos Cancer Institute.
• Developed and implemented comprehensive project plans and robust SOPs, enhancing the efficiency and accuracy of environmental specimen handling.
• Developed training materials and conducted training of HFHS nursing staff and field lab personnel, significantly boosting team competence and performance.
• Orchestrated mock audits to maintain a state of continual inspection readiness.

• Involved in developing molecular biology methodologies for prostate cancer research.
• Attended various meetings, conferences, and scientific training groups to keep pace with emerging field developments.
• Analyzed research data for utilization in publications and grant applications.
• My early career collaborative efforts in developing research methodologies led to contributions in the prostate cancer research field, documented in publications under my former name, Mitrache, in journals like the International Journal of Cancer, Journal of Urology, and Cancer Epidemiology Biomarkers & Prevention.