What are the responsibilities and job description for the Project Associate position at Research & Development Institute, Inc.?
About RDI
RDI is a project-based laboratory that specializes in collecting and testing patient samples to evaluate lab instruments that are not yet available on the market. Since our founding in 2008 by a scientist, we've successfully managed over 150 clinical trials and tested thousands of samples. Our mission is more relevant than ever. As the COVID-19 crisis has demonstrated, accurate laboratory testing is critical-and the work we do at RDI directly contributes to the development of better diagnostic tools for everyone.
General Position Summary
The Project Associate is responsible for performing operational activities that contribute to the successful execution and monitoring of RDI's IVD sample collection trials. This includes delivering agreed-upon services on time and on budget, in accordance with RDI's SOPs, GCP guidelines, and all applicable regulatory requirements.
This is an exciting entry point into the clinical research field for someone who is highly organized, communicative, and collaborative. You will work closely with Project Managers, study teams, physicians, and lab staff to support the full lifecycle of clinical studies-from start-up through closeout.
Essential Job Functions
The Project Associate supports the full lifecycle of clinical sample collection studies-from study start-up through closeout-ensuring high-quality execution in accordance with project timelines, SOPs, and regulatory requirements.
Study Start-Up & Site Support
- Customize and manage regulatory documents; gather training signatures and FDA Form 1572s
- Build and QC sample kits; supervise kit contractors and track kit metrics
- Program and ship scanners, Chromebooks, and other start-up materials to sites
- Create and maintain subject records in Salesforce
- Attend Site Initiation Visits and assist with site onboarding
Study Maintenance
- Monitor site inventory; ensure kits are stocked and not expired
- Manage physician payments through multi-step approval workflows
Data & Sample Management
- QC manifests and test data files per PM specifications
- Receive, accession, and store biological samples according to study protocols
- Assist with inventory tracking and freezer organization
Shipping & Logistics
- Coordinate sample shipments and troubleshoot issues with sites and couriers
- Provide shipping labels and ensure documentation is scanned and filed
Regulatory & Documentation
- Maintain up-to-date regulatory binders and ensure all required study documentation is archived
- Support delegation log completion and closeout document review
- Record temperature and humidity logs for storage compliance
Cross-Functional Collaboration
- Identify process inefficiencies and recommend improvements
- Support study and monitoring teams with regulatory and documentation tracking
- Build positive working relationships with physicians, lab staff, and site personnel
What You'll Bring
- Strong organizational skills with a detail-oriented approach
- Ability to handle multiple projects in a fast-paced, collaborative environment
- Strong communication and problem-solving skills
- Familiarity with supply tracking, regulatory documentation, or clinical research is a plus
- A proactive and adaptable mindset, with enthusiasm for learning and contributing to research impact
