Clinical Research Coordinator II

About the Role

Clinical Renal Associates (CRAL) is seeking an experienced Clinical Research Coordinator II to join our growing research team in Media, Pennsylvania. This role helps lead clinical research activities at the site level — from patient identification and recruitment through study visits, data collection, regulatory compliance, and study closeout. You'll work closely with Principal Investigators, referring providers, clinic staff, and our centralized research team to ensure studies are conducted safely, efficiently, and in accordance with protocol requirements and Good Clinical Practice (GCP).

Patient Recruitment & Enrollment

• Review study protocols and understand eligibility criteria, visit requirements, and study procedures.
• Prescreen patients and proactively identify potential research participants.
• Partner with physicians and clinic staff to communicate research opportunities to eligible patients.
• Support enrollment goals by collaborating with the Central Enrollment Team and broader research organization.
• Conduct and document informed consent in accordance with ICH/GCP and site SOPs.
• Build positive relationships with patients throughout their research journey while prioritizing patient safety and experience.

Study Coordination & Patient Care

• Coordinate and conduct study visits according to protocol-specific schedules and requirements.
• Perform basic clinical procedures including vital signs, height, weight, blood collection, and ECGs.
• Collect, process, and ship laboratory specimens according to protocol requirements.
• Dispense and collect investigational medications and maintain accurate investigational product accountability.
• Monitor and report Adverse Events (AEs) and Serious Adverse Events (SAEs) appropriately to the IRB, sponsor, and management.
• Maintain accurate and complete patient tracking, case report forms (CRFs), and other study documentation.

Data Quality & Compliance

• Complete timely, accurate, and clean data entry in accordance with ALCOA principles.
• Maintain a thorough understanding of study-specific data collection tools and procedures.
• Ensure compliance with study protocols, SOPs, GCP, IATA, FDA regulations, and other applicable requirements.
• Identify and address potential protocol deviations proactively.

Study & Site Management

• Prepare for and support sponsor/monitoring visits by ensuring source documents, logs, and study materials are organized and readily available.
• Resolve monitoring findings and outstanding queries in a timely manner.
• Maintain current temperature logs, investigational product accountability, and other required study documentation.
• Evaluate study resources and proactively develop workflows that improve recruitment, enrollment, patient flow, and overall study execution.
• Partner with clinic and location leadership to ensure appropriate space, staffing, and resources are available for study activities.
• Train site staff on study purpose, procedures, and requirements and maintain appropriate training documentation.

Requirements

• 3–5 years of clinical research experience, preferably in a coordinator role with increasing responsibility.
• Bachelor's degree in a health-related field preferred.
• Medical Assistant (MA) certification preferred.
• Good Clinical Practice (GCP) and/or IATA certification preferred.
• ACRP or SOCRA certification preferred.
• Experience in nephrology, chronic kidney disease (CKD), or vascular access is a plus.
• Bilingual English/Spanish skills preferred.
• Strong knowledge of medical terminology and clinical research processes.
• Working knowledge of GCP, IATA, FDA regulations, and research compliance requirements.
• Ability to perform basic clinical procedures, including blood draws, vital signs, height/weight measurements, and ECGs.
• Highly organized with exceptional attention to detail and the ability to manage multiple studies and a high volume of patients.
• Strong interpersonal and communication skills with the ability to collaborate effectively with physicians, patients, clinical staff, sponsors, and research teams.
• Self-motivated and proactive, with a strong focus on patient safety, data quality, enrollment performance, and study compliance.
• Flexible and comfortable working in a fast-paced clinical research environment.

Why Join CRAL

At CRAL, you'll have the opportunity to be part of a research program focused on improving care for patients with kidney disease and related conditions. You'll work alongside experienced physicians and research professionals while gaining exposure to meaningful clinical studies and having a direct impact on patients. If you're an experienced Clinical Research Coordinator who is ready to take ownership of site-level research operations and help bring important new therapies to patients, we'd love to hear from you.