Quality Assurance Specialist

Location: San Diego CA

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 Alzheimers Disease (AD) through innovative clinical trials.

Quality Assurance Specialist is responsible for the daytoday 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 reengineering. 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 nontherapeutic protocols will be educated and trained on current industry standards.

Experience

• Bachelors degree in science/healthcare related field required.
• A minimum of 3 years experience in clinical research; a candidate with an Alzheimers Disease experience or background is preferred
• A minimum of 2 years experience working with TMF and/or eTMF system software
• Strong knowledge of ICHGCP 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 problemsolving 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 setup 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 crossfunctional 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 offsite 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 closeout 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

USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance and with due consideration for patient and student safety. Please refer to theBackground Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.

The hourly rate range for this position is $36.43 $46.22. 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 candidates work experience education/training key skills internal peer equity federal state and local laws contractual stipulations grant funding as well as external market and organizational considerations.

USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance and with due consideration for patient and student safety. Please refer to theBackground Screening Policy Appendix Dfor specific employment screen implications for the position for which you are applying.

We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone ator by email at. Inquiries will be treated as confidential to the extent permitted by law.

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