Project Administrator
Project Administrator
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$ 77215 - 107844
1 Vacancy
Job Description
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 Alzheimers 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 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 TMFrelated 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 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:
Masters 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.
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 the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.
The annual base salary range for this position is $77215.84 $107844.71. 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 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.
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.
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.
- Notice of Nondiscrimination
- Employment Equity
- Read USCs Clery Act Annual Security Report
- USC is a smokefree environment
- Digital Accessibility
If you are a current USC employee please apply to thisUSC job posting in Workday by copying and pasting this link into your browser:
Experience:Unclear Seniority
Employment Type
Full-Time
Key Skills
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