Senior Clinical Research Coordinator

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.

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 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

Requirements

Associate’s or Bachelor’s degree in a scientific, healthcare, or related discipline required; 5+ years of clinical research or healthcare experience required; Must be able to perform blood draw, medical review (blood pressure, height, weight etc.) & 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 of time; Ability to lift and move up to 25 pounds as needed

Nice to have

CCRC® — Certified Clinical Research Coordinator or CCRP® — Certified Clinical Research Professional or equivalent clinical research certification strongly preferred