Clinical Research Coordinator II

What You'll Do

• Lead clinical research studies at the site level under the direction of the Principal Investigator.
• Review and understand study protocols, evaluate study feasibility, and prepare the site for new clinical trials.
• Pre-screen and recruit eligible patients through collaboration with physicians, clinic staff, and referral sources.
• Educate patients on research opportunities and obtain informed consent in accordance with ICH/GCP guidelines.
• Develop and implement workflows that optimize patient recruitment, enrollment, and study execution.
• Partner with the Central Research Team and Central Enrollment Team to achieve enrollment goals.
• Schedule and coordinate protocol-required patient visits while minimizing protocol deviations.
• Perform clinical research procedures including: Vital signs, Height and weight, Blood collection/phlebotomy, ECGs, Specimen collection and processing, Dispense and reconcile investigational products while maintaining accurate accountability records.
• Complete electronic and paper Case Report Forms (CRFs) with timely, accurate data entry following ALCOA principles.
• Report Adverse Events (AEs) and Serious Adverse Events (SAEs) to sponsors, IRBs, and leadership within required timelines.
• Maintain source documentation, regulatory binders, temperature logs, accountability logs, and study documentation in preparation for sponsor monitoring visits.
• Resolve data queries promptly and ensure ongoing regulatory compliance.
• Train clinic staff on study protocols and maintain documentation of training attendance.
• Cook with clinic leadership to ensure adequate space, equipment, and resources for study activities.
• Perform additional research-related responsibilities as assigned.

Qualifications

• Minimum of 3-5 years of clinical research coordination experience.
• Strong knowledge of Good Clinical Practice (GCP), FDA regulations, and clinical research processes.
• Experience managing multiple clinical trials simultaneously.
• Knowledge of medical terminology.
• Excellent organizational, communication, and interpersonal skills.
• Strong attention to detail with the ability to prioritize competing responsibilities.
• Self-motivated with a commitment to patient safety, protocol compliance, and data quality.
• Bachelor's degree in a health-related field preferred.
• Medical Assistant (MA) certification preferred.
• AACP or SOCRA certification preferred.
• Good Clinical Practice (GCP) and/or IATA certification preferred.
• Experience in nephrology, chronic kidney disease (CKD), vascular access, or related therapeutic areas preferred.
• Bilingual (Spanish) preferred.