Quality Assurance Specialist

Quality Assurance Specialist

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials. 

Quality Assurance Specialist is responsible for the day-to-day management of study TMFs, ensuring that industry standards of quality are being met and exceeded on an ongoing basis, and that TMFs are always inspection ready. The individual will be responsible for providing education and support to trial team staff in the implementation of, and adherence to processes and workflows, controlled documents, tools, and templates to enhance the quality of study documents and the TMF. Incumbent will identify process improvement opportunities and will support process re-engineering. Incumbent will contribute to the development of training materials while serving as a subject matter expert in both QA, QC and TMF. Incumbent will participate in the creation of a quality and education program through which staff involved in the conduct of clinical research, therapeutic and non-therapeutic protocols, will be educated and trained on current industry standards.

Experience

• Bachelor’s degree in science/healthcare related field required. 
• A minimum of 3 years experience in clinical research; a candidate with an Alzheimer’s Disease experience or background is preferred
• A minimum of 2 years experience working with TMF and/or eTMF system software
• Strong knowledge of ICH-GCP and CFR 21
• Monitoring or Quality Assurance experience is required
• Thorough understanding of records management requirements in FDA regulated trials
• Ability to build and maintain positive relationships with management and peers and able to work successfully in a team environment
• Excellent organizational and planning skills, including strong attention to detail
• Excellent written and verbal skills required
• Display strong analytical and problem-solving skills
• Demonstrated capacity to synthesize information from various sources, analyze the information and communicate it to others
• Proficient in Microsoft Office Suite

Responsibilities

• Act as subject matter expert and TMF point of contact for study teams and partners
• Performs key TMF duties in accordance with established guidelines and work instructions (e.g., TMF set-up, management, completeness and timeliness monitoring, reports and metrics, closeout, and TMF quality control (QC)/ quality assurance (QA) activities, etc.)
• Responsible and accountable for the overall TMF quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, including third party documents, TMF tracking and reporting to internal and external team members
• Ensures the TMF file structure follows applicable and approved TMF configuration, ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model
• Ensures sponsor/partner request for TMF retrieval, reproduction, and filing of requested records or electronic images (e.g. PDF, jpeg) are met in a timely manner
• Ensure proper classification and metadata of uploaded documents filed by trial team; may upload documents as needed
• QC review and approve documents to ensure that all new and updated documents are accurately entered in the eTMF for inspection readiness
• Proactively assists project staff in tracking that essential documents are received and maintained across assigned studies
• Participate in Study Team meetings and provide/present TMF metric updates
• Assists with the development and maintenance of study records/ training materials, SOPs, and guidelines and may perform training new and existing staff as required
• identify trends, risks, and associated actions for assigned projects
• Assists with activities for transfer, delivery, and off-site archival of study records
• Assist with audit/inspection related activities (e.g., preparation, corrective action)
• Assist with reviewing updates to project plans, TMF Filing Guidance, SOPs, and Work Instructions as they relate to job functions or assignments
• Collaborate with study teams to ensure all appropriate documents have been filed prior to specific study milestones (e.g., site activation, amendments, close-out and TMF delivery) or according to contract requirements
• Keep current on TMF Reference Model updates, industry best practices and regulatory requirements
• Other duties as assigned

Location:  San Diego, CA

The hourly rate range for this position is $31.87 - $47.88. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual

Minimum Education: Bachelor's degree Additional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Skills: General working knowledge and proficiency in the areas of: documentation to comply with regulatory agency requirements and audit procedures. Demonstrated use of various computer software programs. Experience participating in quality assurance activities. Ability to advise on project procedures and analysis techniques.