Quality Assurance Specialist Assistant Project Manager

Mass General Brigham•Somerville, MA

4d•Hybrid

About The Position

Site: The General Hospital Corporation 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. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Research Organization (ARO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, research nurses, quality specialists, and administrative assistants dedicated to planning and implementing clinical trials. The Quality Assurance Specialist (QAS) will focus on regulatory and quality assurance aspects of clinical research. Receiving general direction from the NCRI Director of Quality Assurance (QA) and Quality Assurance Manager (QAM II), and reporting to the Director/QAM II, the QAS will be responsible for assisting the QA Team with auditing clinical research projects coordinated by the NCRI ARO. Additionally, the QAS will participate in and support the QA Team during external inspections/audits of NCRI conducted by regulatory agencies and industry sponsors. The incumbent will develop tools for documenting and tracking staff qualifications and training, perform periodic reviews of training files of all MGH NCRI employees to ensure that they are complete, and that required training is properly documented and qualifications are maintained. The QAS will assist with drafting and revising NCRI polices and SOPS. The QAS will assist the QA Team in effectively managing the scope, schedule/timelines, and resources of QA-related projects, as well as meeting planning and execution. PRINCIPAL DUTIES AND RESPONSIBILITIES: Relevant activities include, but are not limited to the following: • 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 AND COMPETENCIES 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. EXPERIENCE: Required: • Minimum of one (1) year of working experience related to clinical research, academic research, quality assurance or similar environment required. Preferred: • 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. WORKING CONDITIONS: This position can be either hybrid or remote. Must have reliable internet access. On occasion and at the discretion of the Director of QA, the QAS may be required to be on-site for meetings, sponsor audits or regulatory inspections. Advanced notice will be given. Will travel on public roads and air travel as needed. On occasion, the QAS may be required to travel within the United States to audit investigational sites at the discretion of the Director of QA. Job Summary Summary Fully knowledgeable of the department/trial(s) protocol requirements, works with a high degree of independence, and contributes to implementing process improvements. By virtue of their experience, expected to provide guidance and mentorship to staff regarding department/trial operations.

Requirements

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.
Minimum of one (1) year of working experience related to clinical research, academic research, quality assurance or similar environment required.

Nice To Haves

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.

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.