Sr. Clinical Research Specialist II

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

As the Senior Clinical Research Specialist II, you will work to integrate Iterative Health (IH) services and technology solutions at GI based, clinical research sites throughout the US. This external-facing role will require strong communication, customer  engagement and deep expertise in clinical research, in addition to a strong strategic skill set. You’ll work directly with a portfolio of sites to ensure they achieve their research goals. 

• →Act as an SME on the clinical research services team in implementing best practices for specific areas of clinical research through training and mentorship
• →Demonstrate advanced knowledge of clinical research processes and tools, such as CTMS, pre-screening, and/or feasibility, and enhance these processes and outputs to effectively support our sites or internal teams
• →Serve as a subject matter expert on clinical research workflows, in line with specific requirements of each protocol
• →Manage customer relationships with a high degree of professionalism and expertise ensuring timely responses, escalations of site issues, and building trust needed to help sites achieve their research goals. Manage relationships with site managers, staff, and PIs at priority sites with high volume and high complexity
• →Leverage IH services and solutions to help build best practice research sites and accelerate clinical trials
• →Deliver customized training for different clinical research user groups and devise process  maps/workflows, tools, and techniques to help sites incorporate IH services
• →Devise process maps/workflows, tools, and techniques to help sites incorporate IH services and AI solutions
• →Travel to customer sites to support study site activation, drive patient screening, and  standby support for randomization activities 
• →Collect, analyze, and communicate the voice of IH customer successes, concerns, and product adoption issues/competency gaps and collaborate with IH cross-functional teams to design and deliver solutions 
• →Identify improvements needed to reach team goals and KPIs. Lead relevant projects/approaches with manager alignment 

Required Qualifications

• Minimum 5 years of clinical research coordinator 
• Experience with phase 2-4 pharma-sponsored clinical trials, including  study start-up, CDA, feasibility, regulatory/standard operating procedures, study  protocols, and regulations governing clinical research 

• Experience coordinating, evaluating, and following patients’ participation through clinical  trials
• Fluent in the use of Microsoft Office/Google Apps products
• Ability to navigate ambiguity and willingness to be flexible/adapt to changing work  environments
• Desire to work with new tools and technology
• Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately
• Willingness to travel to customer sites (~30%) 
• BS/BA or higher degree

Preferred Qualifications

• 5+ years as a Clinical Research Coordinator (CRC) working with GI (IBD) and/or Hep (MASH) trials
• 8+ years of experience with phase 2-4 pharma-sponsored clinical trials
• General understanding of the evaluation and diagnosis of Inflammatory Bowel Disease  (IBD) and/or Metabolic dysfunction-associated steatohepatitis (MASH)
• Experience with CTMS systems - preferably RealTime or CRIO