Senior Clinical Research Coordinator
About The Position
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Iterative 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. At Iterative Health, you’ll have the opportunity to help shape the future of clinical research while working alongside a collaborative, mission-driven team. We believe research changes lives, and every team member plays a critical role in improving patient access to innovative therapies.
Requirements
- 5+ years of clinical research or healthcare experience
- 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
Nice To Haves
- Associate’s or Bachelor’s degree in a scientific, healthcare, or related discipline preferred
- Experience in [gastroenterology, hepatology, cardiology] therapeutic areas preferred
- CCRC® — Certified Clinical Research Coordinator or CCRP® — Certified Clinical Research Professional or equivalent clinical research certification 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 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
