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Clinical Research Coordinator III – Nephrology

Clinical Renal Associates | Exton, PA

Clinical Renal Associates (CRA) is seeking an experienced and motivated Clinical Research Coordinator III to lead clinical research operations at our Exton, Pennsylvania location.

This is an exciting opportunity to join a growing research program focused on advancing treatments and improving outcomes for patients with chronic kidney disease, kidney-related disorders, and vascular access conditions. The ideal candidate is a proactive clinical research professional who thrives in a fast-paced environment, excels at patient engagement, and is passionate about bringing innovative therapies to patients through clinical trials.

As a Clinical Research Coordinator, you will work closely with Principal Investigators, sponsors, research participants, and clinical staff to ensure the successful execution of clinical studies while maintaining the highest standards of patient safety, regulatory compliance, and data quality.

What You'll Do

Lead Study Operations

• Review, interpret, and implement clinical trial protocols.
• Evaluate site readiness and coordinate resources necessary for study execution.
• Train physicians, clinic staff, and research personnel on study requirements and procedures.
• Develop and implement workflows that improve recruitment, enrollment, and study performance.
• Serve as the primary site coordinator for assigned studies.

Drive Patient Recruitment & Enrollment

• Identify, prescreen, and recruit eligible patients for clinical trials.
• Collaborate with physicians and clinic staff to increase awareness of study opportunities.
• Educate patients on study participation and obtain informed consent in accordance with ICH/GCP guidelines and site policies.
• Partner with centralized research teams to achieve enrollment goals and study milestones.

Coordinate Participant Care

• Schedule and manage study visits according to protocol requirements.
• Perform protocol-required clinical procedures, including:
• Vital signs
• Height and weight measurements
• Blood collection and specimen processing
• Electrocardiograms (ECGs)
• Collect, process, and ship laboratory specimens according to study protocols.
• Monitor participant safety and ensure adherence to study requirements.

Ensure Regulatory Compliance & Data Quality

• Maintain accurate and timely source documentation and study records.
• Complete electronic and paper Case Report Forms (CRFs) in accordance with ALCOA principles.
• Report adverse events (AEs) and serious adverse events (SAEs) to sponsors, IRBs, and leadership within required timelines.
• Maintain investigational product accountability and study documentation.
• Ensure compliance with FDA regulations, Good Clinical Practice (GCP), protocol requirements, and site SOPs.

Prepare for Monitoring Visits

• Maintain study documentation in an audit-ready state.
• Coordinate sponsor and CRO monitoring visits.
• Resolve data queries and outstanding action items promptly.
• Maintain temperature logs, accountability records, and essential regulatory documentation.

Qualifications

Required

• 5+ years of clinical research experience as a Clinical Research Coordinator or similar role.
• Strong knowledge of clinical trial conduct, GCP, FDA regulations, and research documentation requirements.
• Experience coordinating multiple studies simultaneously.
• Knowledge of medical terminology and clinical procedures.
• Ability to work independently while collaborating effectively with physicians, sponsors, and site staff.
• Strong organizational, communication, and problem-solving skills.
• Ability to perform basic clinical procedures, including phlebotomy, specimen processing, vital signs, and ECGs.

Preferred

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

Why Join Clinical Renal Associates?

• Contribute to innovative research that advances kidney care and improves patient outcomes.
• Work alongside experienced nephrologists and research professionals.
• Play a leadership role in a growing clinical research program.
• Enjoy a collaborative, patient-centered culture focused on quality and excellence.
• Build your research career within a respected nephrology practice committed to innovation and clinical excellence.

Join Clinical Renal Associates and help bring the next generation of kidney care treatments to patients throughout our community.

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