Clinical Research Coordinator II

Iterative Health•San Marcos, TX

About The Position

Iterative Health is a healthcare technology and services company that accelerates clinical research to improve patient outcomes. It operates a network of more than 100 research sites across the US, Europe, India, and Australia, conducting research in communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. The company combines clinical trial expertise with AI to connect sponsors with research teams. It is headquartered in Cambridge, Massachusetts, and New York City, and has more than 250 employees worldwide. The Clinical Research Coordinator II independently coordinates daily clinical trial activities and helps ensure compliance with study protocols, regulatory requirements, and patient safety guidelines. The role manages complex studies with minimal oversight and works with patients, investigators, sponsors, CROs, and internal teams to support high-quality study execution and enrollment. Responsibilities span study start-up through closeout, participant recruitment and care, clinical procedures, data and documentation quality, monitoring and audit support, and site operations. The coordinator may also help onboard and mentor junior research staff.

Requirements

Associate’s or Bachelor’s degree in a scientific, healthcare, or related discipline.
3–5 years of clinical research or healthcare experience.
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.

Nice To Haves

Experience in gastroenterology, hepatology, or cardiology therapeutic areas.
CCRC® (Certified Clinical Research Coordinator), CCRP® (Certified Clinical Research Professional), or equivalent clinical research certification.
Familiarity with CTMS or EDC systems.

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 meeting study timelines and requirements.
Lead patient recruitment and retention activities, including chart review, patient outreach, informed consent discussions, and enrollment tracking.
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 according to 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.
Enter study data accurately and resolve data queries within sponsor expectations and established timelines.
Serve as a primary point of contact for study participants throughout their participation.
Communicate 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 timely investigator review and documentation.
Maintain inventory and organization of onsite study equipment, supplies, and investigational products.
Contribute to process improvement initiatives to enhance site performance, operational efficiency, and patient experience.
Protect human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policies.
Maintain compliance with site SOPs, privacy standards, and research protocols.
May support onboarding and mentorship of junior research staff and coordinators.
Perform job-related duties as requested.