Clinical Research Coordinator II — Lead Patient-Centric Trials

TAU Ventures; New Albany (IN); On-site; USD 60,000 - 95,000; Full time

Job summary

Iterative Health, a healthcare technology and services company, seeks a Clinical Research Coordinator II to autonomously manage industry-sponsored trials from start-up to closeout. You’ll oversee complex visit schedules, recruit and retain patients, and ensure protocol adherence, data integrity, and regulatory compliance.

In collaboration with investigators, sponsors, and CROs, you will lead visits, perform required procedures, and maintain documentation while supporting site operations and

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
• CCRC® or CCRP® or equivalent clinical research certification preferred
• Strong organizational skills and attention to detail
• Ability to manage competing priorities in a fast-paced environment
• Proficiency with CTMS, EDC systems, and standard office software applications
• Familiarity with CTMS or EDC systems preferred

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

Skills

Organizational skills

Communication

Attention to detail

Prioritization

CTMS/EDC proficiency

Regulatory compliance knowledge

Education

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

Tools

CTMS

EDC systems

Office software

Job description

Iterative Health, a healthcare technology and services company, seeks a Clinical Research Coordinator II to autonomously manage industry-sponsored trials from start-up to closeout. You’ll oversee complex visit schedules, recruit and retain patients, and ensure protocol adherence, data integrity, and regulatory compliance.

In collaboration with investigators, sponsors, and CROs, you will lead visits, perform required procedures, and maintain documentation while supporting site operations and