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Senior Clinical Research Coordinator

Iterative Health

Senior Clinical Research CoordinatorFlowood, MIIterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.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 ImpactLead and independently manage complex industry-sponsored clinical trials from study start-up through closeoutCoordinate complex study visit schedules and protocol-related activities while ensuring compliance with study timelines and regulatory requirementsLead patient recruitment and retention initiatives to support enrollment performance and patient engagement goalsMentor and support junior coordinators and research staff on clinical trial processes, patient interactions, sponsor communication, and operational best practicesConduct protocol-required patient visits and assessments in accordance with study protocols, GCP guidelines, and site SOPsPerform protocol-required clinical procedures including vital signs, ECGs, specimen collection, investigational product accountability, and phlebotomy, as permitted by applicable regulations, training, and organizational policyProcess laboratory specimens and prepare shipments in accordance with protocol requirements and applicable IATA regulationsMaintain accurate and timely study documentation including source records, informed consent forms, CTMS updates, and case report formsEnsure high-quality data entry and timely resolution of sponsor and CRO data queriesServe as a primary point of contact for study participants, sponsors, CROs, investigators, and site leadershipBuild strong relationships with investigators, referring physicians, sponsors, and CRO partners to support study success and patient engagementPrepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspectionsReview safety reports and ensure timely investigator review and documentationMaintain inventory and oversight of study equipment, supplies, and investigational products onsiteAssess operational challenges, identify solutions, and recommend process improvements to enhance site performance and protocol adherenceSupport site performance initiatives related to enrollment, screen failures, protocol compliance, and patient retentionContribute to onboarding, training, and mentorship activities for new research staffSupport the protection of human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policiesMaintain compliance with all site SOPs, privacy standards, and research protocolsPerform job related duties as requestedWhat You Bring to the TeamAssociate's or Bachelor's degree in a scientific, healthcare, or related discipline required5+ years of clinical research or healthcare experience requiredMust be able to perform blood draw, medical review (blood pressure, height, weight etc.) & EKGs, as applicable by state lawCCRC® — Certified Clinical Research Coordinator or CCRP® — Certified Clinical Research Professional or equivalent clinical research certification strongly preferredStrong understanding of GCP, FDA regulations, and clinical research operationsDemonstrated ability to independently manage complex clinical trials and competing prioritiesExperience mentoring or supporting junior research staffStrong written and verbal communication skillsStrong organizational skills, attention to detail, and problem-solving capabilitiesProficiency with CTMS, EDC systems, and standard office software applicationsPhysical RequirementsAbility to sit, stand, and move throughout clinical and office environments for extended periods of timeAbility to lift and move up to 25 pounds as neededAt Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact View email address on click.appcast.io.

Vacancy posted 5 days ago
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