NewClinical Director BCBA JobotClinical Director BCBABoston, MA$100,000–$130,000 / yearWe are a rapidly growing, BCBA-founded ABA organization committed to delivering compassionate, outcomes-driven autism services across center-based, home-based, school, and community settings. The Clinical Director will partner closely with executive leadership to drive clinical excellence, improve operational outcomes, mentor BCBA Supervisors, and support the continued expansion of services to families across assigned regions.
Clinical Trial Manager IconmaClinical Trial ManagerBoston, MA$26.16–$28.34 / hourAdvise RSP policy owner/committee chair on policy style, writing, programming; collaboration with subject matter experts; alignment of policy directives, procedural job aids, and committee direction. Identify available resources, including needed mentoring, partnerships, for example, SRG, scientific writing core, CCRO, biostats core, IRB, budget development].
Clinical Research Nurse II, Oncology IconmaClinical Research Nurse II, OncologyBoston, MA$70.02–$72.19 / hourCoordinates with clinical research coordinators and collaborates with staff within respective disease groups and with outside organizations in the completion of clinical research trials. Position requires tact and diplomacy to successfully motivate/educate subjects and staff, and knowledge of research regulations and research compliance requirements, including Protection of Human Subjects.
NewDialysis Clinical Manager Registered Nurse - RN Fresenius Medical CareDialysis Clinical Manager Registered Nurse - RNQuincy, MA$99,694–$166,109 / yearOther: • Collaborates closely with, providing oversight as needed to, the Clinical Manager/Charge RN acting as nurse manager, the Medical Director, and the physicians regarding the direct patient care responsibilities within the facility to ensure the provision of outstanding quality of patient care, as defined by the FMS quality goals, and compliance with the pertinent company policies and procedures. • Demonstrated leadership competencies and management skills for the position, including excellent communication, customer service, continuous quality improvement, relationship development, results orientation, team building, motivating employees, performance management and decision making.
Associate Director, Clinical Assay Strategy, Flu CSL SeqirusAssociate Director, Clinical Assay Strategy, FluWaltham, MA$179,000–$212,000This role is intended for a recognized subject matter expert who understands the scientific, operational, and regulatory evolution of influenza immunogenicity assessment, including HAI, microneutralization (MN), ELLA, and multiplex platforms, and can strategically navigate assay modernization while maintaining regulatory alignment. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness.
NewAssociate Director Clinical Operations JouléAssociate Director Clinical OperationsWaltham, MACollaborate with internal cross-functional teams, clinical sites, and CRO partners to execute global clinical programs in a safe, ethical, and compliant manner. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
NewStudent Social Work Clinical Placement Fresenius Medical CareStudent Social Work Clinical PlacementSaugus, MAPRINCIPLE RESPONSIBILITIES AND DUTIES RELATED TO PATIENT CARE: Patient Assessment/Care Planning Counseling: As a member of the interdisciplinary team, assesses patients' psychosocial status, strengths and areas of need that may affect rehabilitation and optimal treatment outcomes as part of the comprehensive patient assessment. Supports the FMCNA commitment to the Quality Enhancement Program (QEP) and CQI Activities, including those related to patient satisfaction and actively participates in process improvement activities that enhance the likelihood that patients will achieve the FMC Quality Enhancement Goals (QEP).
Research Coordinator JouléResearch CoordinatorBoston, MA$25–$28 / hourProject Manager and team members with all phases of clinical research, including Trial Initiation, Coordination, Implementation, Maintenance, and Close-out. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
NewAssociate Director, Medical Affairs - # 26-15505 US Tech Solutions, Inc.Associate Director, Medical Affairs - # 26-15505Cambridge, MAReporting to the Senior Director, Medical Affairs (Adult Cholestatic Diseases) , the Associate Director, Medical Affairs, will support and oversee select medical affairs activities related to biliary atresia . In collaboration with the Medical Communications Director, lead development of high-quality scientific and educational materials, including: MSL slide decks.
Senior Manager, Special Projects, Center for Clinical Research Advancement Integrated Resources, IncSenior Manager, Special Projects, Center for Clinical Research AdvancementBoston, MAEquipped with extensive experience in program and system design and implementation; integration of research compliance requirements into operational workflows; formation and leadership of institutional committees and workplan initiatives; and career and cultural development, the Senior Manager, Special Projects, is adept in shifting priorities as needed, ready to take on a wide variety of institutional interests. o Recommend process and systems enhancement to Clinical Trial Office Director and collaborate with BClientHS research and non-research departments to implement changes within Client and BClientHS wide systems, including but not limited to, Epic enhancements and other affiliated system integrations.
Clinical Research Manager I - Emergency Department Boston Children's HospitalClinical Research Manager I - Emergency DepartmentBoston, MA$78,540.80–$125,652.80 / yearLead the day-to-day operations, supervision, and development of the Clinical Research team, ensuring staff have the training, resources, and support needed to successfully recruit participants and execute study activities across a portfolio of research studies. Provide ongoing performance management, coaching, and guidance to clinical research staff while ensuring adherence to study protocols, institutional policies, and regulatory requirements; collaborate closely with Principal Investigators to address study needs and priorities.
Assistant Clinical Research Manager - Breast Oncology Clinical Trials Dana-Farber Cancer Institute IncAssistant Clinical Research Manager - Breast Oncology Clinical TrialsBOSTON, MA$70,000–$85,300 / yearThese positions, in collaboration with the program's Clinical research Managers physicians and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program's clinical research activities, related regulatory oversight, and will provide day to day supervision of their program's clinical research staff as needed. This Assistant Clinical Research Manager (ACRM) position will work within the Breast Oncology clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator.
Assistant Clinical Research Manager - Center of Early Detection & Intervention Blood Cancers Interventional Clinical Trials Dana-Farber Cancer Institute IncAssistant Clinical Research Manager - Center of Early Detection & Intervention Blood Cancers Interventional Clinical TrialsBOSTON, MARemote$70,000–$85,300 / yearThe Assistant Clinical Research Manager (ACRM) position will work within the Center of Early Detection & Intervention Blood Cancers (CEDI BC) Interventional Clinical Trials clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. These positions, in collaboration with the program's Clinical research Managers physicians and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program's clinical research activities, related regulatory oversight, and will provide day to day supervision of their program's clinical research staff as needed.
Clinical Research Center Manager Joslin Diabetes CenterClinical Research Center ManagerBoston, MassachusettsAs needed, provide age specific care to pediatric and adult patients with or without diabetes mellitus in a collaborative practice, by using competencies in history taking, physical examination, assessment and interpretation of laboratory and related diagnostic tools for purposes of screening and safety assessments of participants participating in clinical research studies. The Joslin Clinic Research Center Manager is a practitioner who provides care as well as supervision, management, and leadership to support the daily operations and future direction of the Joslin Clinical Research Center (CRC).
NewClinical Research Assistant Adams ClinicalClinical Research AssistantBoston, MA$24–$26.92 / hourWorking under the direct supervision of a CRC II, CRC III, or Site Manager, the RA assists with operational, administrative, and participant-facing tasks to ensure studies run smoothly and in accordance with ICH-GCP, regulatory requirements, and protocol guidelines. Assist with investigational product (IP) accountability tasks as needed and where applicable, gaining exposure to IP handling, tracking, and documentation under the direct supervision of CRC staff, while ensuring adherence to protocol and site SOPs.
NewClinical Manager - Oncology Exeter HospitalClinical Manager - OncologyNHIn partnership withBeth Israel Deaconess Medical Center (BIDMC), we deliver comprehensive inpatient and outpatient oncology services, ensuring patients have seamless access to advanced treatments, specialized expertise, clinical research, and supportive care throughout every stage of their cancer journey. The Clinical Manager partners with physicians, advanced practice providers, and interdisciplinary teams to ensure the delivery of safe, high-quality, patient-centered oncology care while supporting staff engagement, professional development, regulatory compliance, and operational excellence.
Clinical Trial Manager Kymera TherapeuticsClinical Trial ManagerWatertown, MA$115,000–$200,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
Sr Program Manager - Clinical Research Operations Northeastern UniversitySr Program Manager - Clinical Research OperationsBoston, MA$87,785–$123,998.75 / yearWe are seeking an expert Senior Program Manager of Clinical Research Operations to provide high-level operational, regulatory, and strategic management across multiple active research projects. With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role.
Senior Manager, Clinical Operations Adams ClinicalSenior Manager, Clinical OperationsWatertown, MA$120,000–$140,000 / yearSupport subject recruitment, eligibility assessments, randomization, and oversee study processes including ALCOA-compliant documentation, study trackers, investigational product handling, and ensure proper handling of participant safety events and adverse events (SAE/AESI reporting). Oversee facility and building maintenance, including office services, safety inspections, drug room security, and pest control, while ensuring efficient use of site space and adequate workspaces for staff.
Senior Clinical Research Associate (level dependent on experience) CTISenior Clinical Research Associate (level dependent on experience)Boston, MassachusettsFor that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward. To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance.
Senior Manager Clinical Study Lead (Clinical Experimental Sciences) Regeneron Pharmaceuticals IncSenior Manager Clinical Study Lead (Clinical Experimental Sciences)Cambridge, MA$150,500–$245,500 / yearThe CES Ops portfolio is dynamic in nature; study types include, but are not limited to, less complex data transfer agreements, retrospective sample/data acquisition studies to more complex prospective studies including sample/data acquisition, biomarker/technology/method validation, genotypic/phenotypic call back studies, and challenge/screening studies. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study/research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study.
Sr./Clinical Trial Manager - Clinical Operations Aktis Oncology IncSr./Clinical Trial Manager - Clinical OperationsBoston, MAAktis' most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies.
Associate Director, Clinical Supplies Project Manager ModernaTXAssociate Director, Clinical Supplies Project ManagerCambridge, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. The scope includes the operational planning and strategy required to execute end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations.
Clinical Research Coordinator CareerscapeClinical Research CoordinatorBoston, MA$50,000–$65,000 / yearTemporaryThe Clinical Research Coordinator will manage the day-to-day operational requirements of assigned studies, including patient enrollment, protocol adherence, data collection, and regulatory documentation. The position requires direct interaction with study participants, sponsor representatives, and institutional review boards, and demands a working knowledge of FDA regulations and Good Clinical Practice guidelines.
Per Diem Clinical Research Nurse - Home Visits Science 37Per Diem Clinical Research Nurse - Home VisitsManchester, NH$50–$55 / hourWith interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials.
NewClinical Research Coordinator Mass General BrighamClinical Research CoordinatorDanvers, MassachusettsThe framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission.
Clinical Trial Manager ICONMA, LLCClinical Trial ManagerBoston, MA$26.16–$28.34 / hourAdvise RSP policy owner/committee chair on policy style, writing, programming; collaboration with subject matter experts; alignment of policy directives, procedural job aids, and committee direction. Identify available resources, including needed mentoring, partnerships, for example, SRG, scientific writing core, CCRO, biostats core, IRB, budget development].
NewAssociate Director, Clinical Data Management, Hybrid Merck & Co IncAssociate Director, Clinical Data Management, HybridBoston, MA$142,400–$224,100 / yearor B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 6 years' experience in Clinical Data Management or a mix between Data Management and Clinical Research and at least 3 years' experience working with formal project management tools and processes -OR-. Principle Trial Managers will possess end-to-end data management knowledge with strong project management and leadership skills which are transferable from pipeline to process to special initiatives.
Clinical Research Program Manager Mass General BrighamClinical Research Program ManagerBoston, MassachusettsThe Center for Precision Psychiatry (CPP) at Mass General Hospital is seeking applications for a full-time Project Manager to work on projects led by Dr. Matthew Nock aimed at better understanding short-term suicide risk and testing innovative new interventions to prevent suicidal behavior. Ideal candidates will bring strong project management abilities, outstanding written and verbal communication skills, advanced organizational and technology skills, and the ability to work independently while building effective relationships across all levels of the organization.
NewClinical Research Coordinator Brigham and Women's HospitalClinical Research CoordinatorDanvers, MA$21–$29.01 / hourThe framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission.
Senior Clinical Research Finance Specialist Iterative Scopes IncSenior Clinical Research Finance SpecialistMA$85,000–$105,000 / yearYou will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Clinical Research Finance Specialist Iterative Scopes IncClinical Research Finance SpecialistMA$75,000–$85,000 / yearYou will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Clinical Research Program Manager Brigham and Women's HospitalClinical Research Program ManagerBoston, MAThe Center for Precision Psychiatry (CPP) at Mass General Hospital is seeking applications for a full-time Project Manager to work on projects led by Dr. Matthew Nock aimed at better understanding short-term suicide risk and testing innovative new interventions to prevent suicidal behavior. Ideal candidates will bring strong project management abilities, outstanding written and verbal communication skills, advanced organizational and technology skills, and the ability to work independently while building effective relationships across all levels of the organization.
Senior Clinical Research Finance Specialist Iterative HealthSenior Clinical Research Finance SpecialistCambridge, MA$85,000–$105,000 / yearYou will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Clinical Research Finance Specialist Iterative HealthClinical Research Finance SpecialistCambridge, MA$75,000–$85,000 / yearBy combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Sr. Clinical Research Specialist - Site Ops Iterative Scopes IncSr. Clinical Research Specialist - Site OpsMA$85,000–$105,000 / yearThrough the Iterative Health Site Network - a premier network of 100+ clinical research sites across the US and Europe - we help expand and expedite access to novel therapeutics for patients in need. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Clinical Research Coordinator II - Breast Oncology Dana-Farber Cancer Institute IncClinical Research Coordinator II - Breast OncologyBoston, MA$56,000–$63,700 / yearThe CRC (Clinical Research Coordinators) work within the Breast Oncology clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
Associate Principal Scientist, Clinical Research Merck & Co IncAssociate Principal Scientist, Clinical ResearchBoston, MA$142,400–$224,100 / yearTranslational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients. Leads and directs teams through key study planning, development, and execution activities, including program overviews, issue escalation and mitigation, senior management presentations, cross-functional governance meetings, and advisory meeting preparation.
NewClinical Research Biopsy Coordinator Mass General BrighamClinical Research Biopsy CoordinatorBoston, MassachusettsThe framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. The primary role of this position is to assume the responsibility for coordination of the scheduling of tissue procurement within the various clinical trial timelines and ensure that the tissue procurement and processing is carried out per clinical trial laboratory manual specifications.
Sr. Clinical Research Specialist - Site Ops Iterative HealthSr. Clinical Research Specialist - Site OpsCambridge, MA$85,000–$105,000 / yearWe built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.
Clinical Research Director - Rare Diseases SanofiClinical Research Director - Rare DiseasesCambridge, MA$178,500–$257,833.33 / yearExperience / Skills: MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization. On Clinical Development, the CRD: Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes.
Principal Scientist, Clinical Research - Immunology/Dermatology Merck & Co IncPrincipal Scientist, Clinical Research - Immunology/DermatologyBoston, MA$255,800–$402,700 / yearAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
NewClinical Research Biopsy Coordinator Brigham and Women's HospitalClinical Research Biopsy CoordinatorBoston, MA$21–$29.01 / hourThe framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. The primary role of this position is to assume the responsibility for coordination of the scheduling of tissue procurement within the various clinical trial timelines and ensure that the tissue procurement and processing is carried out per clinical trial laboratory manual specifications.
Lead Clinical Data Manager Karwell TechnologiesLead Clinical Data ManagerCambridge, MACollaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals. Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.
Senior Clinical Scientist SanofiSenior Clinical ScientistCambridge, MA$148.50–$214.50 / hourBut progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Senior Clinical Studies Associate DeephealthSenior Clinical Studies AssociateSomerville, Massachusetts$71,000–$96,000 / yearFull timeWorking under the guidance of Clinical Study Manager and cross-functional study teams, the SCSA contributes to study operations, documentation, regulatory compliance, and process improvement initiatives. This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking.
NewClinical Research Data Specialist I Mass General BrighamClinical Research Data Specialist IBoston, MassachusettsPrincipal Duties and Responsibilities: The CRDS I will perform the following responsibilities under general supervision by the Clinical Research Manager: · Proactively track assigned research subject’s upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker. General Summary/Overview Statement: The Clinical Research Data Specialist I (CRDS I) works under general supervision to extract clinical data and research data from electronic medical records and other sources and enters this data into electronic data capture system utilized for the clinical research protocol.
Fellow in Human-Machine Interface Clinical Research - Bionics Lab Harvard UniversityFellow in Human-Machine Interface Clinical Research - Bionics LabCambridge, MA$50,000–$70,000 / yearThe Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) Bionics Lab (https://bioniclab.seas.harvard.edu/) is seeking a highly motivated Fellow with a background in Biomedical Engineering, Mechanical Engineering, or Neural Engineering to join our interdisciplinary research team. You will work at the intersection of neuroscience, engineering, and clinical science, gaining hands-on experience with human subject research, robotics, and electrophysiological data analysis, while contributing to impactful translational research.
Manager, Clinical Research Specialist Training THV AR (Remote US) Edwards Lifesciences CorpManager, Clinical Research Specialist Training THV AR (Remote US)Boston, MARemote$126,000–$178,000 / yearResponsible for maintaining an audit ready environment for all aspects of regulatory and non-regulatory audits as it relates to training (e.g., conducting training, identifying SMEs, ensuring the collection of required documentation.) Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery.