Clinical Research Coordinator - Nephrology Trials

U.S. Renal Care, Inc.; Live Oak (FL); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Medical / Pharmacy

Dental

Vision

401k with employer match

PTO

Life Insurance

Virtual Care

Job summary

U.S. Renal Care, Inc. seeks a Clinical Research Coordinator to coordinate daily clinical trial activities at the site, working with the PI, SCR, sponsors and CROs. You will ensure proper informed consent, accurate data capture, and adherence to FDA, ICH, and HIPAA requirements.

The role involves collaborating with the clinical team, handling source documents, managing IP use guidance, and assisting in site initiation and regulatory inspections. Strong communication skills are essential.

Qualifications

• Bachelor's degree in related field or equivalent.
• 1–3 years of clinical research experience, nephrology preferred.
• Basic knowledge of FDA regulations, IRB requirements and GCP.
• Strong verbal and written communication skills.
• Intermediate computer skills; proficiency in USRC applications within 90 days.

Responsibilities

• Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
• Ensure and document that the informed consent process has occurred properly.
• Assist in maintaining and updating each participant's source records and documentation of procedures.
• Promptly report adverse events, protocol deviations and unanticipated problems to the PI, Sponsor, and IRB.
• Ensure thorough protocol-based education on informed consent, IP use and safety.
• Provide timely exchange of participant information with the PI and research team.
• Adhere to HIPAA and protect participant confidentiality.
• Dispense and instruct participants on IP under protocol and PI direction.
• Collaborate with the clinical team to ensure compliance with the study protocol.
• Perform data collection, source documentation, and entry into CRFs/IWRS; address sponsor queries.
• Aid in long-term storage of research records per contractual requirements.

Skills

Strong communication

Regulatory knowledge

Team player

Microsoft Office proficiency

Education

Bachelor's degree in related field

Tools

Microsoft Office Suite

Job description

U.S. Renal Care, Inc. seeks a Clinical Research Coordinator to coordinate daily clinical trial activities at the site, working with the PI, SCR, sponsors and CROs. You will ensure proper informed consent, accurate data capture, and adherence to FDA, ICH, and HIPAA requirements.

The role involves collaborating with the clinical team, handling source documents, managing IP use guidance, and assisting in site initiation and regulatory inspections. Strong communication skills are essential.