Clinical Regulatory Specialist

Iterative Health • Tyler, TX

2d • Hybrid

About The Position

Iterative Health is a healthcare technology and services company focused on accelerating clinical research to improve patient outcomes. The Iterative Health Site Network is a leading network of over 100 clinical research sites in the US and Europe, dedicated to speeding up the market entry of new therapies. By leveraging deep expertise in clinical trials and advanced AI, we support research teams and study sponsors in broadening and accelerating patient access to innovative treatments. The company is a pioneer in applying AI-based precision medicine to gastroenterology to optimize clinical trials, using machine learning and computer vision to analyze endoscopic videos and other data for better patient assessment and the establishment of more meaningful endpoints. This role is crucial in advancing research through streamlined processes, aiming to deliver treatment options to patients more quickly and efficiently.

Requirements

• Experience in clinical research, regulatory, and compliance in Phase 2-4 sponsor initiated clinical trials
• Familiar with adhering to Good Clinical Practices (GCP), FDA guidelines, and Standard Operating Procedures (SOPs)
• Strong organizational, decision-making, time management, multi-tasking, and prioritization skills
• Ability to communicate effectively both internally and with external customers
• 2+ years of relevant work experience
• Previous experience as a clinical research coordinator or a site facing clinical regulatory dedicated research role

Nice To Haves

• Previous experience using a clinical trial management system (CTMS) is preferred

Responsibilities

• Working alongside research sites on essential regulatory document completion, ISF filing, and study correspondence
• Facilitating clinical trial regulatory activity from study start-up through closeout
• IRB submissions on behalf of sites
• Participating in monitor visits and site level audits
• May serve as a primary point of contact for clinical site staff

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed