Clinical Research Coordinator II - Clifton, NJ

Iterative Health•Clifton, NJ

12d

About The Position

As a Clinical Research Coordinator II at Iterative Health, you will independently coordinate daily clinical-trial activities and help ensure compliance with protocol requirements, regulatory standards, and patient-safety guidelines. The role manages complex studies with minimal oversight and partners with patients, investigators, sponsors, CROs, and internal teams to support high-quality study execution and enrollment success. The coordinator manages industry-sponsored clinical trials from study start-up through closeout; oversees study visits, recruitment, retention, assessments, procedures, specimens, documentation, and data; and supports monitoring visits, audits, and inspections. The role also maintains study supplies and investigational products, contributes to process improvements, protects research participants, and may help onboard and mentor junior research staff. Duties are performed in accordance with study protocols, GCP, applicable regulations, HIPAA, site SOPs, privacy standards, and institutional policies.

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 ensuring adherence to study timelines and requirements.
Lead patient recruitment and retention, 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.
Ensure high-quality data entry and timely resolution of data queries according to sponsor expectations and established timelines.
Serve as a primary point of contact for study participants throughout their study 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.