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.
PSI CRO Burlingame, California, USA Office
401 California Ave, Burlingame, United States, 94010
Similar Jobs
Artificial Intelligence • Fintech • Insurance • Marketing Tech • Software • Analytics
Handle inbound insurance sales calls and warm leads, consult customers to match coverages, convert leads to policyholders, complete paid licensing/training, and meet shift and work-at-home requirements.
Top Skills:
20 Mbps Up)PcWired High-Speed Internet (100 Mbps Down
Digital Media • Information Technology • News + Entertainment
Serve as technical product owner for inventory data assets, define product strategy and priorities, partner with engineering and business, integrate and analyze data across Teradata/SQL Server/Hadoop/AWS, lead exploratory analysis and predictive forecasting, present insights to executives, and promote data-driven decision-making.
Top Skills:
AWSHadoopSQLSQL ServerTeradata
Digital Media • Information Technology • News + Entertainment
Lead AI alignment, roadmap, and execution for Operations & Service Delivery—prioritizing AI use cases, driving workflow transformation, governance, metrics, cross-functional delivery, and building AI operational capability and teams to realize business outcomes.
Top Skills:
AIAnalyticsData
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
