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Iterative Health is a healthcare technology and services company accelerating clinical research to transform patient outcomes. The company operates a network of 100+ research sites across the US, Europe, India, and Australia, conducting trials in gastrointestinal, hepatology, obesity, and cardiology. Combining clinical trial expertise with AI, Iterative Health connects pharmaceutical sponsors with high-performing research teams to expedite access to novel therapeutics. Headquartered in Cambridge, MA and New York City with 250+ employees worldwide.
As a Senior Clinical Research Coordinator (Sr. CRC), 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.
Key responsibilities include: leading and independently managing complex industry-sponsored clinical trials from start-up through closeout; coordinating complex study visit schedules and protocol-related activities while ensuring compliance with timelines and regulatory requirements; leading patient recruitment and retention initiatives; mentoring and supporting junior coordinators and research staff on clinical trial processes, patient interactions, sponsor communication, and operational best practices; conducting protocol-required patient visits and assessments in accordance with study protocols, GCP guidelines, and site SOPs; performing clinical procedures including vital signs, ECGs, specimen collection, investigational product accountability, and phlebotomy as permitted by regulations and training; processing laboratory specimens and preparing shipments per protocol and IATA regulations; maintaining accurate and timely study documentation including source records, informed consent forms, CTMS updates, and case report forms; ensuring high-quality data entry and timely resolution of sponsor and CRO data queries; serving as primary point of contact for study participants, sponsors, CROs, investigators, and site leadership; building strong relationships with investigators, referring physicians, sponsors, and CRO partners; preparing for and supporting sponsor, CRO, and regulatory monitoring visits, audits, and inspections; reviewing safety reports and ensuring timely investigator review and documentation; maintaining inventory and oversight of study equipment, supplies, and investigational products; assessing operational challenges and recommending process improvements; supporting site performance initiatives related to enrollment, screen failures, protocol compliance, and patient retention; contributing to onboarding, training, and mentorship activities for new research staff; and supporting protection of human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policies.
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.), and EKGs as applicable by state law; CCRC® (Certified Clinical Research Coordinator) or CCRP® (Certified Clinical Research Professional) or equivalent clinical research certification strongly 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.
