Healthcare Technology, Artificial Intelligence, Biotechnology

Clinical Research Coordinator II

Waterford, CTOnsiteFull TimePosted 2 months agoVisa sponsorship available

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Required skills

Clinical Research Coordinator
GCP
HIPAA
IATA
CTMS
EDC systems
Protocol
Patient Safety
Study Start-up
Study Closeout

Nice to have

CCRC®
CCRP®
Gastroenterology
Hepatology
Cardiology
Process Improvement

Role summary

Iterative Health is seeking a Clinical Research Coordinator II (CRC II) to independently manage clinical trials, ensuring compliance with protocols, regulations, and patient safety. This role involves leading patient recruitment, conducting protocol-required visits and procedures, maintaining accurate documentation, and serving as a key point of contact for participants and stakeholders. The CRC II will also support process improvements and ensure adherence to all site SOPs and research policies. A scientific or healthcare degree and 3-5 years of clinical research or healthcare experience are required, with preferred experience in gastroenterology, hepatology, or cardiology, and relevant certifications.

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.

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 Impact

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

What You Bring to the Team

Associate’s or Bachelor’s degree in a scientific, healthcare, or related discipline required

3-5 years of clinical research or healthcare experience required

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

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

Familiarity with CTMS or EDC systems preferred

Physical Requirements

Ability to sit, stand, and move throughout clinical and office environments for extended periods of time

Ability to lift and move up to 25 pounds as needed

At 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 CandidateAccommodations@iterative.health.

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