Senior Clinical Research Coordinator II - Complex Trials

Socket.dev; Providence (RI); On-site; USD 60,000 - 90,000; Full time

Job summary

Iterative Health is seeking a Clinical Research Coordinator II to independently coordinate day-to-day study activities and ensure protocol compliance and patient safety. You will manage complex trial schedules, lead recruitment and retention efforts, and perform protocol-driven visits and procedures in alignment with GCP and SOPs.

You will maintain study documentation, support sponsor visits, monitor safety data, and collaborate with sponsors, CROs, investigators, and site teams to drive

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.
• Experience in gastroenterology, hepatology, or cardiology therapeutic areas preferred.
• CCRC® - Certified Clinical Research Coordinator or CCRP® - Certified Clinical Research Professional or equivalent 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.

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

CTMS proficiency

EDC systems

Organizational skills

Prioritization

Communication skills

Education

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

Tools

CTMS

EDC systems

Office software

Job description

Iterative Health is seeking a Clinical Research Coordinator II to independently coordinate day-to-day study activities and ensure protocol compliance and patient safety. You will manage complex trial schedules, lead recruitment and retention efforts, and perform protocol-driven visits and procedures in alignment with GCP and SOPs.

You will maintain study documentation, support sponsor visits, monitor safety data, and collaborate with sponsors, CROs, investigators, and site teams to drive