Job Description
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.
Responsibilities
- Assist 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 goals
- Lead the onboarding program for new hires at NCRI
- Periodically review qualifications and training files for NCRI ARO employees for completeness and report deficiencies to the Director of QA
- Responsible 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 system
- Plan and manage periodic reviews of NCRI policies and SOPs
- Assign and track training on policies and SOPs for NCRI staff
- Assist the QA Team with performing periodic quality assurance audits of research projects managed by the NCRI ARO
- Assist the QA Team with internal review of staff adherence to NCR written procedures
- Responsible for the collection and maintenance of computer system validation and change request documentation in Qualio
- Assist with the development of project-related plans such as training plans, TMF plans, and quality management plans
- Assist with investigational site audits for assigned projects
- Assist with drafting responses to audit findings by external auditors
- Assist with vendor qualification, including working with vendors to collect and review quality-related documents
- Coordinate quality assurance initiatives and training sessions for MGH NCRI staff
- Accept responsibility for special projects as requested
Skills
- Minimum of one (1) year of working experience related to clinical research, academic research, quality assurance or similar environment required
- Bachelor's Degree Related Field of Study required
- High level of time management and organizational skills
- Excellent leadership, written and verbal communication skills
- A basic understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidelines and regulations related to the conduct of clinical research trials
- Excellent computer skills working with Microsoft Office
- Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously
- The ability to develop and manage positive relationships with sponsor representatives, study team members, and vendors
- Background/familiarity with biology or other scientific disciplines is preferred, but not required
- Experience with Quality Assurance in a clinical research setting is preferred, but not required
- Previous Industry Clinical Trial experience 2-3 years required and Data Management experience 2-3 years preferred
Benefits
- Comprehensive benefits
- Career advancement opportunities
- Differentials
- Premiums and bonuses as applicable
- Recognition programs designed to celebrate your contributions and support your professional growth
Company Overview
Company H1B Sponsorship
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