As a Senior Clinical Research Coordinator (Sr. CRC) at Iterative Health 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 to help drive successful study execution, enrollment performance, and regulatory compliance.
Where You'll Drive Impact- Lead and independently manage complex industry-sponsored clinical trials from study start-up through closeout
- Coordinate complex study visit schedules and protocol-related activities while ensuring compliance with study timelines and regulatory requirements
- Lead patient recruitment and retention initiatives to support enrollment performance and patient engagement goals
- 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 protocol-required clinical procedures including vital signs, ECGs, specimen collection, investigational product accountability, and phlebotomy, as permitted by applicable regulations, training, and organizational policy
- Process laboratory specimens and prepare shipments in accordance with protocol requirements and applicable 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 a primary point of contact for study participants, sponsors, CROs, investigators, and site leadership
- Build strong relationships with investigators, referring physicians, sponsors, and CRO partners to support study success and patient engagement
- 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 onsite
- Assess operational challenges, identify solutions, and recommend process improvements to enhance site performance and protocol adherence
- 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
- Support the protection of human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policies
- Maintain compliance with all site SOPs, privacy standards, and research protocols
- Perform job related duties as requested
What You Bring to the Team
- Associate's or Bachelor's degree in a scientific, healthcare, or related discipline preferred
- 5+ years of clinical research or healthcare experience
- Experience in [gastroenterology, hepatology, cardiology] therapeutic areas preferred
- CCRC® - Certified Clinical Research Coordinator or CCRP® - Certified Clinical Research Professional or equivalent clinical research certification 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 Requirements- Ability to sit, stand, and move throughout clinical and office environments for extended periods of time
- Ability to lift and move up to 25 pounds as needed
