Clinical Research Coordinator II

Nephrology Associates, Inc. | Providence, RI

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.

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.

• 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…