Clinical Research Coordinator II

Iterative Health is a healthcare technology and services company that accelerates clinical research to improve patient outcomes. The Clinical Research Coordinator II independently coordinates complex clinical trials, manages study visits and patient recruitment, conducts protocol-required assessments and procedures, maintains study documentation and data quality, and ensures compliance with regulatory and patient safety requirements.

Responsibilities

• Independently coordinate and manage industry-sponsored clinical trials from study start-up through closeout with minimal supervision
• Manage complex study visit schedules and protocol-related activities while ensuring adherence to study timelines and requirements
• Lead patient recruitment and retention efforts including chart review, patient outreach, informed consent discussions, and enrollment tracking to support study enrollment goals
• 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, complete, 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 data queries in accordance with sponsor expectations and established timelines
• Serve as a primary point of contact for study participants throughout study participation
• Maintain ongoing communication with sponsors, CROs, investigators, site leadership, and internal teams to proactively resolve study-related issues
• Prepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspections
• Review safety reports and ensure appropriate investigator review and documentation in a timely manner
• Maintain inventory and organization of study equipment, supplies, and investigational products onsite
• Contribute to process improvement initiatives to enhance site performance, operational efficiency, and patient experience
• 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
• May support onboarding and mentorship of junior research staff and coordinators
• Perform job related duties as requested

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
• Familiarity with CTMS or EDC systems preferred
• Gastroenterology experience
• Hepatology experience
• Cardiology experience
• CCRC certification
• CCRP certification
• Clinical research certification
• CTMS familiarity
• EDC system familiarity

Company

• Clinical research technology and services for accelerating novel therapies
• Cambridge, Massachusetts, USA
• https://iterative.health/
• Founded in 2017
• 51-200 employees

Qualifications

• Associate's or Bachelor's degree in a scientific, healthcare, or related discipline required
• 3-5 years of clinical research or healthcare experience required
• Strong organizational skills and attention to detail
• Ability to manage competing priorities in a fast-paced environment
• Ability to read, interpret, and apply research protocols and clinic policies
• Proficiency with CTMS, EDC systems, and standard office software applications
• 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
• Familiarity with CTMS or EDC systems preferred

Required skills

• Clinical Practice (GCP), Clinical Procedures, Clinical Research Certification, Clinical Research Coordination, Clinical Trial Management, Clinical Trial Management Systems (CTMS), Clinical Trial Protocol Interpretation, Electrocardiography (ECG), Electronic Data Capture (EDC) Systems, HIPAA Compliance, IATA Regulations, Investigational Product Accountability, Phlebotomy, Priority Management, Specimen Collection and Processing

Preferred skills

• $268.6M, 2021-08-03, 2022-01-19, 2026-04-30, 2026-05-14, 2026-07-10, 2026-08-11, AI Tools, Aditya Khosla, Business Wire, CEO, CTO & Board Member, Cambridge, Massachusetts, USA, Clearlake Capital Group,Insight Partners, Company data provided by, Customize Your Resume, Familiarity with CTMS or EDC systems preferred, Google Ventures,Intrepid Growth Partners, Growth Stage, Jonathan Ng, Key Investors, Leadership Team, Maximize your interview chances, Obvious Ventures, Recent News, Series A· $30M, Series B· $150M, Series C· $77M, Total Funding, https://iterative.health

Experience

• 3-5 years