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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 worldwide and headquarters in Cambridge, MA and NYC, Iterative Health combines clinical trial expertise with AI to connect 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'll coordinate daily study activities while ensuring strict compliance with protocols, regulatory standards, and patient safety guidelines.
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 per GCP guidelines and site SOPs
- Perform clinical procedures including vital signs, ECGs, specimen collection, and phlebotomy as permitted
- Process laboratory specimens and prepare shipments per IATA regulations
- Maintain accurate, complete, and timely study documentation including source records, ICFs, 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 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 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) or equivalent clinical research certification (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
