University of Southern California
Project Administrator
University of Southern California, San Diego, California, United States, 92189
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.ATRI is looking for a Project Administrator to serve as a Quality Assurance (QA) representative and will be responsible for supporting inspection readiness of the ATRI, particularly in the areas of Trial Master File (TMF) and internal and external audits. Incumbent will contribute to the creation and implementation of strategies to maintain the integrity of the quality system.Key responsibilities include
but are not limited to:Support study specific deliverables and milestones of TMF(s)Perform TMF quality reviews and provide status reportsSupport study teams in the resolution of TMF-related queries or quality issuesAssist in the development and execution of audit/inspection procedures, including TMFProtect the integrity of the quality system by promoting the consistent application of standards and best practicesEvaluate documents, records and procedures, including audit materials, to ensure they comply with regulations, policies, procedures and customer requirementsRecommend improvement initiatives based on identified areas of improvementEssential skills and abilities:Analytical skills / assessment / evaluationAttention to detailPlanning, organization, and time managementProblem identification, reporting, resolutionCommunication – written and oralGathering data / evidenceResearch information / regulations / requirementsKnowledge of applicable principlesInterpretation of policies and trendsInterviewing / questioning – asking the right questions - listeningConceptualizationTact, diplomacyAbility to handle multiple ongoing projects or tasksStays informed of developments in field by reading pertinent literature, attending meetings, and participating in professional associations as appropriate.Working knowledge of clinical trials, medical terminology as it pertains to clinical trials, and/or research concepts, ICH guidelines and Good Clinical Practices (GCP). Ability to collaborate with all members to gather, interpret and consolidate data, generate documentation and reporting, review data and information for presentation and review.Preferred education:Master’s degree or combined experience/education as substitute for education.Preferred experience:3 or more years of experience preferred.Preferred Field of Expertise:Experience with Trial Master File (preferably DIA Reference Model) and monitoring or auditing. Ability to work collaboratively in a team setting. Familiarity with Microsoft Office and Microsoft Excel. Ability to analyze data and familiarity with data analytics procedures and software. Ability to analyze and conduct problem solving. Ability to train and motivate others and ability to work effectively with diverse populations. Excellent written and oral communication skills. Pharmaceutical or Device Research experience.The annual base salary range for this position is $77,215.84 - $107,844.71. 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 stipulations, grant funding, as well as external market and organizational considerations.Location: San Diego, CaliforniaMinimum Education:
Master's degree, Combined experience/education as substitute for minimum educationMinimum Experience:
3 years, Combined education/experience as substitute for minimum experienceMinimum Field of Expertise:
Directly related education and project administration experience in specialized field represented by project.
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but are not limited to:Support study specific deliverables and milestones of TMF(s)Perform TMF quality reviews and provide status reportsSupport study teams in the resolution of TMF-related queries or quality issuesAssist in the development and execution of audit/inspection procedures, including TMFProtect the integrity of the quality system by promoting the consistent application of standards and best practicesEvaluate documents, records and procedures, including audit materials, to ensure they comply with regulations, policies, procedures and customer requirementsRecommend improvement initiatives based on identified areas of improvementEssential skills and abilities:Analytical skills / assessment / evaluationAttention to detailPlanning, organization, and time managementProblem identification, reporting, resolutionCommunication – written and oralGathering data / evidenceResearch information / regulations / requirementsKnowledge of applicable principlesInterpretation of policies and trendsInterviewing / questioning – asking the right questions - listeningConceptualizationTact, diplomacyAbility to handle multiple ongoing projects or tasksStays informed of developments in field by reading pertinent literature, attending meetings, and participating in professional associations as appropriate.Working knowledge of clinical trials, medical terminology as it pertains to clinical trials, and/or research concepts, ICH guidelines and Good Clinical Practices (GCP). Ability to collaborate with all members to gather, interpret and consolidate data, generate documentation and reporting, review data and information for presentation and review.Preferred education:Master’s degree or combined experience/education as substitute for education.Preferred experience:3 or more years of experience preferred.Preferred Field of Expertise:Experience with Trial Master File (preferably DIA Reference Model) and monitoring or auditing. Ability to work collaboratively in a team setting. Familiarity with Microsoft Office and Microsoft Excel. Ability to analyze data and familiarity with data analytics procedures and software. Ability to analyze and conduct problem solving. Ability to train and motivate others and ability to work effectively with diverse populations. Excellent written and oral communication skills. Pharmaceutical or Device Research experience.The annual base salary range for this position is $77,215.84 - $107,844.71. 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 stipulations, grant funding, as well as external market and organizational considerations.Location: San Diego, CaliforniaMinimum Education:
Master's degree, Combined experience/education as substitute for minimum educationMinimum Experience:
3 years, Combined education/experience as substitute for minimum experienceMinimum Field of Expertise:
Directly related education and project administration experience in specialized field represented by project.
#J-18808-Ljbffr