Clinical Research Coordinator II

Clinical Research Coordinator IIWaterford, ConnecticutIterative 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 Clinical Research Coordinator II (CRC II) at Iterative Health you will play a critical role in the successful execution of clinical trials by independently coordinating daily study activities and ensuring compliance with protocol requirements, regulatory standards, and patient safety guidelines.This role is responsible for managing complex studies with minimal oversight while partnering closely with patients, investigators, sponsors, CROs, and internal teams to drive high-quality study execution and enrollment success.Where You'll Drive ImpactIndependently coordinate and manage industry-sponsored clinical trials from study start-up through closeout with minimal supervisionManage complex study visit schedules and protocol-related activities while ensuring adherence to study timelines and requirementsLead patient recruitment and retention efforts including chart review, patient outreach, informed consent discussions, and enrollment tracking to support study enrollment goalsConduct 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, complete, and timely study documentation including source records, informed consent forms, CTMS updates, and case report formsEnsure high-quality data entry and timely resolution of data queries in accordance with sponsor expectations and established timelinesServe as a primary point of contact for study participants throughout study participationMaintain ongoing communication with sponsors, CROs, investigators, site leadership, and internal teams to proactively resolve study-related issuesPrepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspectionsReview safety reports and ensure appropriate investigator review and documentation in a timely mannerMaintain inventory and organization of study equipment, supplies, and investigational products onsiteContribute to process improvement initiatives to enhance site performance, operational efficiency, and patient experienceSupport 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 protocolsMay support onboarding and mentorship of junior research staff and coordinatorsPerform job related duties as requestedWhat You Bring to the TeamAssociate's or Bachelor's degree in a scientific, healthcare, or related discipline required3-5 years of clinical research or healthcare experience requiredExperience in [gastroenterology, hepatology, cardiology] therapeutic areas preferredCCRC® — Certified Clinical Research Coordinator or CCRP® — Certified Clinical Research Professional or equivalent clinical research certification preferredStrong organizational skills and attention to detailAbility to manage competing priorities in a fast-paced environmentAbility to read, interpret, and apply research protocols and clinic policiesProficiency with CTMS, EDC systems, and standard office software applicationsFamiliarity with CTMS or EDC systems preferredPhysical 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.