The posting
Nephrology Associates, Inc. | Providence, RI Advance Clinical Research. Improve Kidney Care. Nephrology Associates, Inc. is seeking an experienced Clinical Research Coordinator II (CRC II) to join our clinical research team in Providence, Rhode Island. This role offers the opportunity to play a key part in the execution of clinical research studies while working closely with investigators, physicians, clinic staff, patients, sponsors, and the broader research team. The CRC II will take ownership of day-to-day study coordination at the site level, with a strong focus on patient recruitment and enrollment, study execution, regulatory and protocol compliance, data quality, and patient safety. The ideal candidate is organized, proactive, and comfortable managing multiple studies and a high volume of patients while maintaining a high standard of accuracy and quality. What You'll Do Study Start-Up & Site Readiness
Read, understand, and operationalize assigned research protocols and study requirements.
Prescreen patients and identify potentially eligible research participants.
Train site staff on study purpose, procedures, and requirements; maintain appropriate training documentation.
Evaluate study resources and coordinate with clinic leadership to ensure the site is prepared for successful study execution.
Develop and implement workflows that improve recruitment, enrollment, patient flow, and study operations.
Patient Recruitment & Enrollment
Proactively identify and recruit potentially eligible patients through collaboration with physicians, clinic staff, and the research team.
Communicate study eligibility criteria and research opportunities to referring physicians and clinic staff.
Partner with the Central Research team, including the Central Enrollment Team, to meet or exceed referral, consent, and enrollment targets.
Obtain and document informed consent in accordance with ICH/GCP, protocol requirements, and site SOPs.
Promote a positive patient experience while prioritizing patient safety and ethical research practices.
Study Coordination & Patient Visits
Coordinate and plan subject visits according to protocol-specific schedules and requirements.
Ensure visits and procedures are completed within protocol-defined windows and minimize protocol deviations.
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 product/medication and maintain accurate accountability records.
Monitor patient participation and maintain accurate patient tracking documentation.
Data & Documentation
Complete case report forms (CRFs), electronic data capture systems, and other study documentation accurately and in a timely manner.
Maintain data integrity in accordance with ALCOA principles: Attributable, Legible, Contemporaneous, Original, and Accurate.
Maintain a thorough understanding of study-specific data collection instruments and ensure data are collected according to protocol.
Report adverse events and serious adverse events to the appropriate IRB, sponsor, and management within required timelines.
Maintain accurate study files, logs, source documentation, and patient records.
Monitoring & Quality Oversight
Prepare for and support sponsor/CRO monitoring visits.
Ensure source documents are organized, complete, and readily available for monitoring.
Respond to monitor follow-up letters in a timely manner and ensure outstanding items are resolved.
Maintain current temperature logs, investigational product accountability records, and other required study documentation.
Resolve data queries and outstanding action items promptly.
Maintain compliance with study protocols, site SOPs, ICH/GCP, IATA, FDA regulations, and applicable research requirements.
Site Operations & Collaboration
Coordinate with location administration to ensure appropriate space, equipment, supplies, and other resources are available for study activities.
Build strong working relationships with physicians, clinic staff, patients, sponsors, CROs, and internal research teams.
Identify operational challenges and proactively implement solutions to improve study performance.
Perform other duties and responsibilities as assigned.
What We're Looking For
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 CKD, nephrology, vascular access, or a related therapeutic area is a plus.
Bilingual English/Spanish skills preferred.
Strong knowledge of medical terminology and clinical research practices.
Working knowledge of GCP, IATA, FDA regulations, and research compliance requirements.
Demonstrated ability to manage multiple studies and a high volume of patients while maintaining quality and attention to detail.
Ability to perform basic clinical procedures, including blood draws, vital signs, height, and weight.
Ability to perform ECGs.
Excellent organizational, interpersonal, written, and verbal communication skills.
Highly self-motivated and proactive, with the ability to independently drive recruitment, enrollment, data quality, and study execution.
Strong attention to detail and commitment to patient safety and research quality.
Ability to multitask, prioritize competing responsibilities, and work effectively in a fast-paced clinical environment.
Why Join Us? This is an opportunity to join a clinical research program focused on advancing care for patients with kidney disease while gaining exposure to the full spectrum of site-level research operations. The CRC II will have meaningful ownership of study execution and the opportunity to make a direct impact on patient recruitment, research quality, and the development of new treatment options for patients with kidney disease.
