Senior Clinical Research Coordinator - Gurnee, IL
About The Position
The Senior Clinical Research Coordinator at Iterative Health is a key member of a clinical research site, overseeing complex studies while supporting staff development, operational performance, and high-quality patient experiences. The role combines hands-on study coordination with mentorship, process improvement, and cross-functional collaboration to support successful study execution, enrollment performance, and regulatory compliance. The coordinator independently manages complex industry-sponsored clinical trials from study start-up through closeout; coordinates study visits and protocol activities; leads recruitment and retention efforts; conducts patient visits and assessments; and performs protocol-required clinical procedures, as permitted by applicable regulations, training, and organizational policy. The role also includes maintaining study records and data, coordinating with participants and research partners, supporting monitoring visits and inspections, and helping improve site operations. The position is located in Gurnee, Illinois. Iterative Health is a healthcare technology and services company conducting clinical research across a network of more than 100 sites. The company is headquartered in Cambridge, Massachusetts, and New York City, and has more than 250 employees worldwide.
Requirements
- Associate’s or Bachelor’s degree in a scientific, healthcare, or related discipline.
- At least 5 years of clinical research or healthcare experience.
- Ability to perform blood draws, medical reviews (including blood pressure, height, and weight), and EKGs, as applicable by state law.
- 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.
- 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.
Nice To Haves
- CCRC® (Certified Clinical Research Coordinator), CCRP® (Certified Clinical Research Professional), or equivalent clinical research certification is strongly preferred.
Responsibilities
- 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 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 site SOPs, privacy standards, and research protocols.
- Perform job-related duties as requested.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
