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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.
As a Senior Clinical Research Coordinator, you will serve as a key team member within the clinical research site, overseeing complex studies while supporting staff development, operational performance, and high-quality patient experiences. This role combines hands-on study coordination with mentorship, process improvement, and cross-functional collaboration.
Key responsibilities include:
- Lead and independently manage complex industry-sponsored clinical trials from start-up through closeout
- Coordinate complex study visit schedules and protocol-related 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, sponsor communication, 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 requirements 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
- Assess operational challenges, identify 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 activities for new research staff
- Ensure compliance with federal regulations, GCP, HIPAA, and institutional policies
Physical requirements include ability to sit, stand, and move throughout clinical and office environments for extended periods, and ability to lift and move up to 25 pounds as needed.
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 draw, 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
