Clinical Regulatory Specialist

Iterative Health

Iterative Health is pioneering the use of artificial intelligence-based precision medicine in gastroenterology, with the aim of helping to optimize clinical trials investigating the treatment of IBD. We use advanced machine learning and computer vision to interpret endoscopic videos along with other types of data, helping clinicians better assess patients with potential GI problems. Ultimately, the company aims to establish more meaningful endpoints to serve as better predictors of both therapeutic response and disease outcomes.

Iterative Health is seeking a Clinical Regulatory Specialist to join our team onsite in Grapevine, Texas, or remote. The Clinical Regulatory Specialist will work under the direction of the Manager of Clinical Regulatory with the primary responsibility of assisting with the conduct and compliance of Phase 2-4 pharma sponsored research studies. This position will be a supportive and collaborative role in an office setting, working with team members, clinical sites, and study sponsors, requiring Administrative and Regulatory work. The best candidates will possess the soft skills that enable them to work and deliver in a fluid, fast-paced environment, think on their feet and outside of the box. They will be a self-starter with a bias toward results and business outcomes, that takes initiative to anticipate and solve problems. This is an exciting time in the Clinical Research industry! Our team is driving the advancement of research by implementing streamlined processes, with a mission of getting treatment options to patients in a faster, more efficient way.

What you’ll be doing:

  • Essential document preparation, organization, data entry and Regulatory compliance maintenance
  • Facilitating successful study start-up, including clinical site and sponsor communication and status reporting
  • IRB submissions on behalf of sites
  • Participating in internal and external audits

Required Skills:

  • Expertise in clinical research, regulatory & compliance and Phase 2-4 sponsored clinical research, with an understanding of the site Study Coordinator role
  • Skilled at adhering to Good Clinical Practices (GCP), FDA essential documents guidelines, and Standard Operating Procedures (SOPs)
  • Excellent communication skills, both written and oral, with a keen attention to detail
  • Strong organizational, decision-making, time management, multi-tasking and prioritization skills
  • Ability to competently use computers, the internet, Adobe, Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams), and clinical trial management system (CTMS)

Some of our benefits include:

  • Vision/Dental/ Medical Insurance
  • Life/Disability Insurance
  • Parental Leave
  • Stock Options
  • Flexible Work Hours
  • Unlimited Paid Time Off

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process.