Senior Clinical Research Associate

About RDI Research & Development Institute (RDI) is a tech-enabled, diagnostics-focused Contract Research Organization (CRO) helping In Vitro Diagnostic (IVD) manufacturers overcome regulatory hurdles to get their products FDA-cleared. We bridge the gap between innovative diagnostics companies and the clinical samples they need by partnering with physicians and laboratories across the U.S.Backed by a major investment in 2021, RDI has evolved from a founder-led startup into a nationally recognized CRO with a CLIA-certified laboratory, cutting-edge capabilities, and a scientific leadership team who remain hands-on with every project. We combine startup energy with operational excellence to deliver fast, compliant, and high-quality clinical research.Position Overview RDI is seeking a Senior Clinical Research Associate (Senior CRA) to lead the execution of clinical trials across multiple diagnostic studies. You’ll play a critical role in ensuring protocol compliance, efficient site management, and high-quality data collection — all while helping RDI scale its trial operations nationally.This is a long-term career opportunity with significant room for advancement. RDI offers a clear path for professional growth, including support toward SOCRA CRA certification and leadership development opportunities.Responsibilities

• Lead the planning, execution, and monitoring of diagnostic clinical trials
• Oversee protocol development, CRF design, and site-level contracting and budgeting
• Serve as primary liaison between sites and RDI — ensuring clear communication, support, and compliance
• Manage IRB submissions and regulatory documentation
• Develop and execute monitoring plans; conduct site qualification, initiation, monitoring, and close-out visits
• Ensure timely resolution of queries, deviations, and data issues
• Maintain and update Diagnostica, RDI’s proprietary CTMS platform
• Provide mentorship to junior CRAs and support process optimization as the team grows
• Collaborate closely with project managers, regulatory, and lab teams to align on study goals

Qualifications

• Minimum 2–4 years of clinical research experience, with at least 1 year as a CRA or senior CRC with audit experience
• Proven ability to manage multiple sites and studies independently
• Deep knowledge of Good Clinical Practice (GCP) and FDA/IVD study requirements
• Exceptional organizational, communication, and problem-solving skills
• Experience with site budgeting and contract negotiation is a plus
• Comfortable working in a fast-paced, entrepreneurial environment
• Willingness to travel as needed (20–30%)
• SOCRA or ACRP certification (or willingness to pursue with RDI support)

What We Offer

• A high-impact, fast-moving role at a growing, mission-driven CRO
• Direct collaboration with senior scientific and operational leaders
• Opportunities for rapid advancement and professional development
• Support for certification and continued education
• Competitive salary and benefits