Project Administrator

Location: San Diego, California

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 who will serve as a Trial Master File (TMF) subject matter expert, support inspection readiness of the ATRI, and participate in the planning and execution of internal and external audits. Incumbent will contribute to the creation and implementation of strategies to maintain the integrity of the quality system by promoting the consistent application of standards and best practices.

Key responsibilities include but are not limited to:

• Lead TMF compliance efforts and operational strategies. Serve as TMF subject matter expert across multiple trials, collaborating with internal teams and external vendors to support inspection readiness
• Support study teams in the resolution of TMF-related queries or quality issues
• Provide education and training to study teams to ensure a high level of data quality and research study compliance
• Effectively convey complex concepts and research principles to others to foster a quality culture
• Support study setup and closeout, including development of TMF indices and plans as well as plans for closeout/archival/transfer as required; participate in user acceptance testing
• Monitor, report and present on the health of the TMF through contemporaneous reviews, quality and completeness checks, and reporting tools
• Identify trends, and drive actions when issues are identified
• Assist with the development, implementation and execution of inspection and audit related activities
• Evaluate documents, records and procedures, including audit materials, to ensure they comply with regulations, policies, procedures and customer requirements
• Recommend improvement initiatives based on identified areas of improvement
• May provide work direction to TMF contractors or internal TMF support
• Oversee TMF user access management as required

Essential skills and abilities:

• Solid understanding of the clinical trial process, medical terminology as it pertains to clinical trials, and/or research concepts, ICH guidelines and Good Clinical Practices (GCP)

• Extensive experience in handling clinical trial related documents and electronic TMF systems and technologies

• Ability to handle multiple ongoing projects and tasks with ability to quickly adapt to changing priorities while maintaining a high level of customer service

• Stays informed of industry best practices by reading pertinent literature, attending meetings, and participating in professional associations as appropriate.

• Ability to collaborate with all members to gather, interpret and consolidate data, generate documentation and reporting, review data and information for presentation and review.

• Knowledge of important research principles including ALCOA+, Good Documentation Practices, GCP, confidentiality, human subjects protection
• Analytical skills / assessment / evaluation including interpretation of policies and trends
• Strong attention to detail
• Proficient at planning, organization, time management and follow through
• Skilled at problem identification and proposing solutions
• Effective and frequent written and oral communication with others using tact and diplomacy
• Gathering data / evidence
• Research information / regulations / requirements
• Interviewing / questioning - asking the right questions - adept listening skills

Preferred education:

Master's degree or combined experience/education as substitute for education.

Preferred experience:

3 or more years of focused TMF experience preferred

Preferred Field of Expertise:

Extensive 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.

Minimum Education: Master's degree, Combined experience/education as substitute for minimum education
Minimum Experience: 3 years, Combined education/experience as substitute for minimum experience
Minimum Field of Expertise: Directly related education and project administration experience in specialized field represented by project.