Clinical Research Coordinator II

The role

The Clinical Research Coordinator II will coordinate all aspects of assigned clinical trials from site initiation through close-out. This role involves conducting subject visits, managing recruitment, and ensuring compliance with protocols and regulations.

What you will do

• Provide the highest level of care for study patients
• Deliver excellent customer service to pharmaceutical clients
• Coordinate all aspects of assigned clinical trials from site initiation through close-out
• Conduct subject visits and ensure accurate, timely documentation in compliance with protocol and standards
• Maintain compliance with protocols, GCP/ICH guidelines, FDA regulations, IRB requirements, and SOPs
• Manage subject recruitment, informed consent, and retention activities
• Ensure timely EDC data entry and resolution of queries
• Report and follow up on AEs, SAEs, and protocol deviations
• Collaborate with investigators, sponsors/CROs, labs, and internal teams
• Prepare for and participate in monitoring visits, audits, and inspections

Required qualifications

• At least one year of experience managing multiple phase 2-4 industry-sponsored clinical trial studies as the primary coordinator
• Bachelor's degree OR 2 years of college in a health-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP
• Strong understanding of FDA regulations, ICH-GCP, and clinical trial operations
• Experience with EDC, IVRS, and clinical research platforms
• Proficiency in medical terminology and clinical documentation
• Strong organizational skills with the ability to manage multiple studies
• Clear, professional verbal and written communication skills
• Comfortable working onsite in a collaborative, clinical environment

About the company

Headlands Research is a leading network of advanced clinical trial sites founded in 2018. The company operates 20+ sites across the US and Canada.