CRC II: Lead Clinical Trials & Enrollment

Iterative Scopes; Waterford (CT); Presencial; USD 60.000 - 85.000; Jornada completa

Descripción de la vacante

Iterative Health in the United States seeks an experienced Clinical Research Coordinator II to independently coordinate complex industry-sponsored clinical trials from start-up through closeout. You will manage visit schedules, consent discussions, and enrollment tracking while ensuring GCP compliance and high-quality data capture.

The role involves conducting protocol-required visits, phlebotomy, sample handling, and collaboration with sponsors, CROs, investigators, and internal teams.

Formación

• 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, or cardiology preferred.
• CCRC® or CCRP® certification preferred.
• Proficiency with CTMS, EDC, and standard office software applications.

Responsabilidades

• 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

Conocimientos

Strong organizational skills

Attention to detail

Ability to manage competing priorities

Proficiency with CTMS/EDC

Interpersonal communication

Educación

Associate’s or Bachelor’s degree in a scientific/healthcare field

Herramientas

CTMS

EDC systems

Descripción del empleo

Iterative Health in the United States seeks an experienced Clinical Research Coordinator II to independently coordinate complex industry-sponsored clinical trials from start-up through closeout. You will manage visit schedules, consent discussions, and enrollment tracking while ensuring GCP compliance and high-quality data capture.

The role involves conducting protocol-required visits, phlebotomy, sample handling, and collaboration with sponsors, CROs, investigators, and internal teams.