Clinical Research Coordinator II

Clinical Research Coordinator II (CRC II)

Kidney & Hypertension Center
Cincinnati, Ohio

Advance the Future of Kidney Care Through Clinical Research

Kidney & Hypertension Center is seeking an experienced Clinical Research Coordinator II (CRC II) to lead clinical research operations at the site level. In this role, you'll work alongside nephrology physicians and research professionals to bring innovative therapies to patients with chronic kidney disease and related conditions while ensuring the highest standards of patient safety, regulatory compliance, and study quality.

If you're an experienced Clinical Research Coordinator who enjoys managing studies from start-up through closeout, building relationships with patients and providers, and driving enrollment success, we'd love to hear from you.

What You'll Do

As the Clinical Research Coordinator II, you will oversee day-to-day study execution while ensuring compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, and site Standard Operating Procedures.

Key Responsibilities

• 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.
• Coordinate with clinic leadership to ensure adequate space, equipment, and resources for study activities.
• Perform additional research-related responsibilities as assigned.

Qualifications

Required

• 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
• Ability to perform clinical procedures including blood draws, vital signs, specimen processing, and ECGs
• 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

Preferred

• Bachelor's degree in a health-related field
• Medical Assistant (MA) certification
• ACRP or SOCRA certification
• Good Clinical Practice (GCP) and/or IATA certification
• Experience in nephrology, chronic kidney disease (CKD), vascular access, or related therapeutic areas
• Bilingual (Spanish)

Why Join Kidney & Hypertension Center?

At Kidney & Hypertension Center, you'll become part of a collaborative team committed to advancing nephrology care through cutting-edge clinical research. You'll have the opportunity to work directly with patients, physicians, and research professionals while contributing to studies that help bring new treatments to individuals living with kidney disease.

We offer a supportive, mission-driven environment where your expertise has a direct impact on improving patient outcomes and advancing the future of nephrology research.

Apply today to help shape the future of kidney care through clinical research.

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