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Iterative Health is a healthcare technology and services company that accelerates clinical research to improve patient outcomes. The company operates a network of 100+ research sites across the US, Europe, India, and Australia, conducting trials in gastrointestinal, hepatology, obesity, and cardiology. With 250+ employees globally and headquarters in Cambridge, MA and New York City, Iterative Health combines clinical trial expertise with AI to connect pharmaceutical sponsors with high-performing research teams.
As a Clinical Research Coordinator II, you will independently manage complex clinical trials from startup through closeout with minimal supervision. You will serve as a key operational leader at the site level, responsible for ensuring protocol compliance, regulatory adherence, and patient safety across multiple concurrent studies.
Key responsibilities include:
- Independently coordinate and manage industry-sponsored clinical trials with minimal oversight
- Manage complex study visit schedules and protocol activities while maintaining adherence to timelines
- Lead patient recruitment and retention efforts including chart review, outreach, informed consent, and enrollment tracking
- Conduct protocol-required patient visits and assessments in accordance with GCP guidelines and site SOPs
- Perform clinical procedures including vital signs, ECGs, specimen collection, and phlebotomy as permitted by regulations and training
- Process and ship laboratory specimens in compliance with IATA regulations
- Maintain accurate, complete, and timely study documentation including source records, informed consent forms, CTMS updates, and case report forms
- Ensure high-quality data entry and timely resolution of data queries
- Serve as primary point of contact for study participants throughout their participation
- Maintain ongoing communication with sponsors, CROs, investigators, and internal teams to resolve issues proactively
- Prepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspections
- Review safety reports and ensure appropriate investigator review and documentation
- Maintain inventory and organization of study equipment, supplies, and investigational products
- Contribute to process improvement initiatives to enhance site performance and patient experience
- Support human research participant protection in compliance with federal regulations, GCP, HIPAA, and institutional policies
- May support onboarding and mentorship of junior research staff
Requirements:
- Associate's or Bachelor's degree in a scientific, healthcare, or related discipline (required)
- 3-5 years of clinical research or healthcare experience (required)
- Experience in gastroenterology, hepatology, or cardiology therapeutic areas (preferred)
- CCRC® (Certified Clinical Research Coordinator) or CCRP® (Certified Clinical Research Professional) certification or equivalent (preferred)
- Strong organizational skills and attention to detail
- Ability to manage competing priorities in a fast-paced environment
- Ability to read, interpret, and apply research protocols and clinic policies
- Proficiency with CTMS, EDC systems, and standard office software applications
- Familiarity with CTMS or EDC systems (preferred)
- Ability to sit, stand, and move throughout clinical and office environments for extended periods
- Ability to lift and move up to 25 pounds as needed
