Quality Assurance/Regulatory Project Coordinator, 40Hrs, BWH TIMI Study at Brigham & Women's Hospital(BWH) in Boston, Massachusetts

Posted in Other 4 days ago.

Type: Full Time





Job Description:

The Quality Assurance (QA) Coordinator works under minimal supervision and is responsible to provide day-to-day coordination of activities that enforce continuous monitoring and improvement of systems, ensure QA / Regulatory milestones and deliverables are met and assure quality and compliance of the TIMI Study Group. The position reports to the Head of Quality Assurance.

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Develops and supports general training materials to improve staff job performance and compliance.
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Supports the management of the Employee trAininG and quaLification databasE (EAGLE) to ensure training assignments are completed, and training documentation is collected and filed appropriately.
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Assists with the management of the SOP module within the EAGLE to ensure that all TIMI internal SOPs are assigned, attested to, and filed appropriately.
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Assists with the conduct and documentation of User Acceptance Testing (UAT) to support system validation of internal and project-specific systems, as needed.
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Supports assessment of Quality Metrics Database (QMD) to ensure site/PI quality issues are reported accurately, follows-up with project teams for supporting documentation and that QA/Regulatory recommendations are provided.
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Assists in the development and maintenance of a detailed schedule of QA milestones and deliverables, to include internal audits and Quality Control (QC) projects.
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Coordinates internal and external resources to achieve QA milestones and deliverables.
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Provides support for external and internal audits to include preparation, conduction, and follow-up.
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Maintain department service standards as outlined in the BWH Code of Conduct.
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Perform other duties as required.

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Bachelors Degree required, in a field of Life Science preferred.
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1 years in a role requiring strong coordination skills, e.g. organization, communication, analysis
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Prior role requiring knowledge of QA principles and theories, preferred, but not required.
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Demonstrated capacity to apply leadership skills, assume responsibility and function under minimal supervision.

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General knowledge of QA principles as they apply to clinical research
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General knowledge of audit functions and conduct
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General knowledge of US and Canadian regulations and guidelines governing clinical research
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General knowledge of good documentation practices in pharmaceutical/medical device/biotechnology industry
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Working knowledge of how to use common office ware (e.g. Computers, Phone, MS Office Software)
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Knowledge of project planning methodologies (e.g. critical path planning)
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Excellent critical thinking, analysis and problem solving skills
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Excellent communication, organizational and interpersonal skills
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Exceptional attention to detail for consistency and clarity
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Ability to attend to multiple projects with strong timelines

Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status or on the basis of disability.