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Provide operational support for clinical study startup in the US: site activation, feasibility research, eTMF tracking, site agreements and budgets, IRB/IEC and IP-RED document collection, communication with sites/vendors, progress reporting, and preparation of study dossiers and audit documentation.
Company Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job DescriptionTake your career to the next level and be involved in study startup processes in the US. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time.
You will:
- Supports all processes critical for site activation.
- Supports Feasibility department with feasibility research and site identification process.
- Maintains project-specific tracking systems and electronic Trial Master File (eTMF) throughout study startup phase.
- Provides administrative support with site agreement and budgets.
- Assists with site documents collection for IRB/IEC submission and/or IP-RED process.
- Provides progress updates to all concerned functions.
- Identifies project-specific issues and escalates as outlined in the project specific Communication Plan.
- Supports preparation of study dossiers to sites and competent authorities.
- Supports preparation of IP-RED packages.
- Ensures exchange of information and documentation with investigational sites, off -site facilities and vendors throughout study startup phase.
- Additional responsibilities may include collecting documents in preparation for audits on a country-region level.
- College/University degree or an equivalent combination of education, training and experience
- At least 1 year industry experience in clinical research and/or a minimum 1 year of Study Startup experience
- Communication and organizational skills
- Ability to negotiate and build relationships at all levels
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
What you need to know about the Los Angeles Tech Scene
Los Angeles is a global leader in entertainment, so it’s no surprise that many of the biggest players in streaming, digital media and game development call the city home. But the city boasts plenty of non-entertainment innovation as well, with tech companies spanning verticals like AI, fintech, e-commerce and biotech. With major universities like Caltech, UCLA, USC and the nearby UC Irvine, the city has a steady supply of top-flight tech and engineering talent — not counting the graduates flocking to Los Angeles from across the world to enjoy its beaches, culture and year-round temperate climate.
Key Facts About Los Angeles Tech
- Number of Tech Workers: 375,800; 5.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Snap, Netflix, SpaceX, Disney, Google
- Key Industries: Artificial intelligence, adtech, media, software, game development
- Funding Landscape: $11.6 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Strong Ventures, Fifth Wall, Upfront Ventures, Mucker Capital, Kittyhawk Ventures
- Research Centers and Universities: California Institute of Technology, UCLA, University of Southern California, UC Irvine, Pepperdine, California Institute for Immunology and Immunotherapy, Center for Quantum Science and Engineering
