Quality Assurance Specialist Assistant Project Manager

Mass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. The Quality Assurance Specialist will assist the QA Team with auditing clinical research projects and participate in external inspections and audits, ensuring regulatory compliance and quality assurance in clinical research activities.ResponsibilitiesAssist with the implementation of specific tasks as outlined in the NCRI Quality Management Plan, which defines QA functions, objectives, tracking processes, action plans, and identifies goalsLead the onboarding program for new hires at NCRIPeriodically review qualifications and training files for NCRI ARO employees for completeness and report deficiencies to the Director of QAResponsible for user management activities for NCRI ARO level electronic applications (Qualio, Adobe Sign, etc.)Act as the lead administrator for Qualio, NCRI’s electronic quality management systemPlan and manage periodic reviews of NCRI policies and SOPsAssign and track training on policies and SOPs for NCRI staffAssist the QA Team with performing periodic quality assurance audits of research projects managed by the NCRI AROAssist the QA Team with internal review of staff adherence to NCR written proceduresResponsible for the collection and maintenance of computer system validation and change request documentation in QualioAssist with the development of project-related plans such as training plans, TMF plans, and quality management plansAssist with investigational site audits for assigned projectsAssist with drafting responses to audit findings by external auditorsAssist with vendor qualification, including working with vendors to collect and review quality-related documentsCoordinate quality assurance initiatives and training sessions for MGH NCRI staffAccept responsibility for special projects as requestedSkillsMinimum of one (1) year of working experience related to clinical research, academic research, quality assurance or similar environment requiredBachelor's Degree Related Field of Study requiredHigh level of time management and organizational skillsExcellent leadership, written and verbal communication skillsA basic understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidelines and regulations related to the conduct of clinical research trialsExcellent computer skills working with Microsoft OfficeTeam player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneouslyThe ability to develop and manage positive relationships with sponsor representatives, study team members, and vendorsBackground/familiarity with biology or other scientific disciplines is preferred, but not requiredExperience with Quality Assurance in a clinical research setting is preferred, but not requiredPrevious Industry Clinical Trial experience 2-3 years required and Data Management experience 2-3 years preferredBenefitsComprehensive benefitsCareer advancement opportunitiesDifferentialsPremiums and bonuses as applicableRecognition programs designed to celebrate your contributions and support your professional growthCompany OverviewMass General Brigham specializes in providing medical treatments and health diagnostics services. It was founded in 1994, and is headquartered in Somerville, Massachusetts, USA, with a workforce of 10001+ employees. Its website is https://www.massgeneralbrigham.org.Company H1B SponsorshipMass General Brigham has a track record of offering H1B sponsorships, with 77 in 2025, 61 in 2024, 93 in 2023, 70 in 2022, 80 in 2021, 29 in 2020. Please note that this does not guarantee sponsorship for this specific role.



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