Clinical Research Coordinator II

Roles and 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

What You Bring to the Team

• 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, cardiology] therapeutic areas preferred
• CCRC® — Certified Clinical Research Coordinator or CCRP® — Certified Clinical Research Professional or equivalent clinical research 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

Physical Requirements

• Ability to sit, stand, and move throughout clinical and office environments for extended periods of time
• Ability to lift and move up to 25 pounds as needed