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Iterative Health is a healthcare technology and services company accelerating clinical research across gastrointestinal, hepatology, obesity, and cardiology. The company operates a network of 100+ research sites globally and combines clinical trial expertise with AI to connect sponsors with high-performing research teams. Headquartered in Cambridge, MA and NYC with 250+ employees worldwide.
As a Senior Clinical Research Coordinator, you will serve as a key operational leader within a clinical research site, managing complex studies while mentoring staff, driving process improvements, and ensuring regulatory compliance.
Key Responsibilities:
- Lead and independently manage complex industry-sponsored clinical trials from start-up through closeout
- Coordinate complex study visit schedules and protocol activities while ensuring compliance with timelines and regulatory requirements
- Lead patient recruitment and retention initiatives to support enrollment performance
- Mentor and support junior coordinators and research staff on clinical trial processes, patient interactions, and operational best practices
- Conduct protocol-required patient visits and assessments in accordance with study protocols, GCP guidelines, and site SOPs
- Perform clinical procedures including vital signs, ECGs, specimen collection, investigational product accountability, and phlebotomy as permitted by regulations and training
- Process laboratory specimens and prepare shipments per protocol and IATA regulations
- Maintain accurate 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 sponsor and CRO data queries
- Serve as primary point of contact for study participants, sponsors, CROs, investigators, and site leadership
- Build strong relationships with investigators, referring physicians, sponsors, and CRO partners
- Prepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspections
- Review safety reports and ensure timely investigator review and documentation
- Maintain inventory and oversight of study equipment, supplies, and investigational products
- Identify operational challenges, develop solutions, and recommend process improvements
- Support site performance initiatives related to enrollment, screen failures, protocol compliance, and patient retention
- Contribute to onboarding, training, and mentorship of new research staff
- Ensure compliance with federal regulations, GCP, HIPAA, and institutional policies
Requirements:
- Associate's or Bachelor's degree in a scientific, healthcare, or related discipline (required)
- 5+ years of clinical research or healthcare experience (required)
- Ability to perform blood draws, medical review (blood pressure, height, weight, etc.), and EKGs as applicable by state law (required)
- CCRC® (Certified Clinical Research Coordinator) or CCRP® (Certified Clinical Research Professional) or equivalent clinical research certification (strongly preferred)
- Strong understanding of GCP, FDA regulations, and clinical research operations
- Demonstrated ability to independently manage complex clinical trials and competing priorities
- Experience mentoring or supporting junior research staff
- Strong written and verbal communication skills
- Strong organizational skills, attention to detail, and problem-solving capabilities
- Proficiency with CTMS, EDC systems, and standard office software applications
- Physical 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
