Clinical Research Coordinator

About This Role

This full-time Clinical Research Coordinator II (CRC II) role involves independently managing and overseeing the implementation and day-to-day conduct of clinical trials. The position is pivotal in ensuring patient safety, maintaining data integrity, and driving enrollment and quality objectives, while strictly adhering to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), International Council of Harmonization (ICH), and regulatory requirements. The CRC II serves as the primary liaison between participants, investigators, and sponsors.

Responsibilities

• Demonstrate mastery of CRC I responsibilities and perform all core coordinator tasks independently, including vitals, phlebotomy, lab processing, and ECGs
• Maintain a strong understanding of study protocols to ensure all site activities strictly adhere to Food and Drug Administration (FDA), GCP, and ICH guidelines
• Independently manage a portfolio of assigned studies, ensuring compliance with protocol requirements, timelines, and site objectives
• Conduct and support the informed consent process under PI supervision; serve as a knowledgeable resource for participants
• Screen and enroll study subjects; manage complex study calendars and reminder systems to ensure strict protocol window compliance
• Collect and document medical history, concomitant medications, and adverse events/serious adverse events (AEs/SAEs) in accordance with protocol and regulatory requirements
• Assume a lead role in the trial start-up phase (with supervision), including the completion of project management duties pertaining to site initiation
• Ensure accurate, contemporaneous data entry in eCRF/EDC systems in alignment with ALCOA principles
• Manage sponsor communication independently, including query resolution, protocol deviation documentation, and study updates
• Support and lead site Pre-study Visits (PSVs), Site Initiation Visits (SIVs), and Interim Monitor Visits (IMVs); prepare required documentation and respond to monitor queries with a high degree of independence
• Perform other duties as assigned
• Track and coordinate subject stipend disbursements within the CTMS; ensure all financial intake forms (e.g., Form W-9) are accurately processed
• Support patient recruitment and retention strategies; participate in outreach initiatives and recruitment events to meet enrollment targets

Requirements

• 2 to 5 years of Clinical Research experience
• Advanced experience with EDC/eCRF systems and Clinical Trial Management Systems (CTMS)
• Ability to manage multiple studies and priorities in a fast-paced environment with minimal supervision
• Strong attention to detail with high accuracy in documentation
• Excellent interpersonal, written, and verbal communication skills