Nephrology CRC: Patient-Focused Trials

U.S. Renal Care; Orange (CT); On-site; USD 74,000 - 92,000; Full time

Benefits offered by this job

Medical / Pharmacy

Dental

Vision

401k with employer match

Life Insurance

Vacation / PTO

Voluntary Benefits

Virtual Care

Job summary

U.S. Renal Care is seeking a Clinical Research Coordinator to manage daily clinical trial activities in collaboration with the PI, SCRC, and sponsor teams. The role ensures protocol adherence, participant safety, and accurate data handling across sites.

The CRC will maintain study documents, facilitate informed consent, and coordinate IP administration while complying with FDA, ICH-GCP, IRB, and HIPAA requirements. Travel may be required between dialysis facilities.

Qualifications

• Bachelor's degree in related field preferred.
• 1–3 years of clinical research experience; nephrology experience preferred.
• Knowledge of FDA regulations, IRB requirements and Good Clinical Practice.
• Knowledge of kidney care and/or ESKD is a plus.
• Strong verbal and written communication skills.
• Intermediate computer skills; proficiency in Microsoft Office and USRC applications within 90 days.

Responsibilities

• Coordinate all aspects of participant care from screening through study completion per protocol and PI delegation.
• Ensure informed consent is obtained according to 45 CFR part 46.
• Maintain and update source records, including medical history and eligibility.
• Promptly report adverse events and protocol deviations to the PI, Sponsor, and IRB.
• Educate participants about study processes, IP use, and safety obligations.
• Exchange participant information with the PI and research team for safety and conduct.
• Protect confidentiality under HIPAA at all times.
• Dispense and instruct on IP use per protocol and PI direction.
• Collaborate with the clinical team to ensure protocol compliance.
• Collect data, document source data, and enter into CRFs/IWRS; address sponsor queries.
• Coordinate long-term storage of research records per contractual requirements.
• Assist in site initiation, monitoring, audits, and inspections.
• Maintain Essential Documents and Trial Master File for compliance.

Skills

Clinical research experience

Nephrology knowledge

Verbal & written communication

FDA regulations/GCP knowledge

Intermediate computer skills

Education

Bachelor's degree in related field preferred

Tools

Microsoft Office

USRC applications

Job description

U.S. Renal Care is seeking a Clinical Research Coordinator to manage daily clinical trial activities in collaboration with the PI, SCRC, and sponsor teams. The role ensures protocol adherence, participant safety, and accurate data handling across sites.

The CRC will maintain study documents, facilitate informed consent, and coordinate IP administration while complying with FDA, ICH-GCP, IRB, and HIPAA requirements. Travel may be required between dialysis facilities.