Faces of Research & Insights: Nicoleta Smith, Research Quality Lead
In this edition of Faces of Research & Insights, we sit down with GenesisCare’s Research & Insights Research Quality Lead, for the United States, Nicoleta Smith, to discuss her passion for quality assurance, her career growth and journey at GenesisCare, her advice to others embarking on a career in quality management, and her role leading the Michigan Radiation Oncology Quality Consortium (MROQC). After making a huge mark and impression on the physicians in Michigan and global research leadership team, Nicoleta was recently promoted to the role of Research Quality Lead for the United States.
At GenesisCare Research & Insights, our unique integrated research model, comprising of our Site Research Organization, Contract Research Organization and US Research Sponsor Unit, means there are endless opportunities for personal career growth and development. Interested in joining the GenesisCare Research & Insights team? We are actively recruiting for several roles across our Site Research Organization and Contract Research Organization.
Learn more about current opportunities today here.
Q: Nicoleta, can you tell us a bit about your career background?
I immigrated to the United States from Romania to complete my Bachelors in Biochemistry at Oakland University here in Michigan. After graduating I began my career in research joining the Henry Ford Health System as a research coordinator. Over the next 13 years I held various roles at Henry Ford Health, working in scientific oncology research, quality management, operations management of the molecular epidemiology research laboratory, and executive management. I joined GenesisCare in 2019 as the Lead Coordinator for Michigan Radiation Oncology Quality Consortium MROQC and just this year commenced a new position as Research Quality Lead, for the United States!
Q: Can you tell us what sparked your interest in a career in oncology research, and specifically quality? How did you move into quality?
Clinical research can make all the difference in terms of saving people’s lives and improving the quality of life of patients living with cancer. I find it extremely rewarding that I am playing a small part and devoting my time and efforts to progressing advancements in oncology and increasing treatment options for patients.
It was during my time at Henry Ford Health in my role as the Manager of the Molecular Epidemiology Research Laboratory, where I became interested specifically in quality assurance in research. At the time, our laboratory was participating in a study called the Michigan Alliance of National Children Study (MANCS), and my role involved partnering really closely with other key institutions across the state, including the University of Michigan, Karmanos Cancer Institute and Wayne State University, to draft study schedules, process improvement workflows, and standard operating procedures. It was a fantastic time and really shaped my career direction; I enjoyed understanding people's roadblocks and collaborating with other institutions to develop new workflows to help all the different workstreams work more efficiently together.
Q: How important is quality control and assurance in oncology research?
High levels of quality are essential to achieving an organization’s business objectives, whether that be in healthcare or any industry. In medical research, quality assurance and management is imperative in ensuring high quality data and patient safety. Quality does not just relate to the end product or services, in this case the approved therapy or treatment approach, it also relates to the way employees go about their jobs, and the work processes they have to follow. Our goal in quality assurance is to ensure work processes are as efficient as possible, and they are continuously improving. We are the overhauling light over all the different parties involved and we can help everyone be successful in their individual roles and business units, as well as the organization as a whole.
Q: You have had a few different roles at GenesisCare and were recently promoted to the role of Research Quality Lead, for the United States. Congratulations! Can you tell us how the team has supported your career growth ambitions?
I’m so proud to have joined the Research Assurance Quality team at GenesisCare Research & Insights, led by Robin Luber and Janet Russell. I’m inspired by their hard work and relentless dedication to our organization, our employees, and the Research & Insights mission. I’ve only been in my new role for a few weeks now but Robin, Janet, and the entire team, have done a brilliant job onboarding me and providing me with educational resources. While the majority of the team are based in Australia, and I’m here in the United States, they’ve done such a fantastic job in welcoming me to the team and giving me a real sense of belonging, that I often forget how physically apart we are! 2023 is going to be a huge year for me in terms of career growth and I’m ready for a steep but exciting learning curve!
GenesisCare’s research leadership team does an outstanding job in rewarding hard work and they really strive to provide employees with career growth opportunities. I’d like to personally thank Kris Barooshian, the physicians in Michigan, Maureen, Robin, Janet, and the entire leadership team, for being so supportive and helping me realize my own career ambitions!
Q: Can you tell us about a project you are most proud of from your time at GenesisCare so far?
I originally joined GenesisCare in 2019 as the Lead Coordinator for the Michigan Radiation Oncology Quality Consortium, led by our MROQC Clinical Champions: Dr. Frank Vicini, Dr. Larry Kestin and Dr. Thomas Boike. It is a state-wide quality initiative that all major oncology healthcare providers are participating in and aims to offer providers best practice guidelines for radiation therapy. At the time I joined, GenesisCare was enrolling between 170 and 200 new patients per year, in addition to managing the follow up of patients from previous years.
My role was to provide training and education to all of the GenesisCare MROQC team members and sites, lead the data abstraction and quality outcomes reporting, and identify opportunities for clinical quality improvement through the implementation of new standard operating procedures and workflows.
Over the past four years, I have had the absolute pleasure of working closely with our brilliant physicians in Michigan, including Dr. Larry Kestin, Dr. Frank Vicini, and Dr. Thomas Boike, to expand GenesisCare’s participation in the initiative. MROQC without a doubt has been a career highlight for me and it has been a tremendous opportunity to work alongside our physicians and to continuously learn from them all and refine my skills. All of the physicians have always offered guidance and support, they are all very action orientated and regardless of how busy they are, they always make the time. I’ve learned so much about oncology research from the project and it has allowed me to further refine and expand my knowledge and core skills in quality assurance.
I’m very proud of the fact that in the past four years we were able to double our enrollment and the GenesisCare MROQC team expanded to two full time MROQC coordinators.
Q: Can you tell us about GenesisCare’s global integrated approach to QA programs for clinical research and some of the systems we have invested in to streamline our processes?
The two key priorities of our Quality Management System are to ensure that patients that volunteer to be involved in human clinical research are safe, and that the data and information generated by research can be relied upon to ultimately improve patient outcomes.
I’m very excited to be involved this year in the roll-out of our global Quality Management System for GenesisCare Research & Insights this year, which will harmonize our efforts, allow learnings from each other, and ultimately facilitate the implementation of global best practice systems and processes.
With the full implementation of Veeva Vault Quality in 2023 across all of Research & Insights as our chosen electronic QMS (eQMS) we will have a fully functioning Document Management system in addition to a research specific Learning Management System.
Q: What would your message be to individuals who are considering a career in quality management in research?
Quality management in research is a fantastic and rewarding career if you are an avid learner, enjoy problem solving and like helping others succeed. It is an incredibly dynamic career and the learning curve never ends with oncology drug development.
In 2011, the Michigan Radiation Oncology Quality Consortium (MROQC) was established, with the support of Blue Cross Blue Shield of Michigan and Blue Care Network. The consortium launched a comprehensive clinical outcomes data registry of patients receiving radiation treatment for breast, lung, and prostate cancer and bone metastases. MROQC is the first-of-its-kind collaborative quality initiative in the United States and today comprises of 26 radiation oncology centers and over 300 members.
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Interested in joining the GenesisCare Research & Insights team? We are actively recruiting for several roles across our Site Research Organization and Contract Research Organization.