Clinical Research Coordinator II/III - Nephrology

Cincinnati Children's

About The Position

The Clinical Research Coordinator supports clinical research studies in the Nephrology department, ensuring study activities comply with protocols, Good Clinical Practice, institutional procedures, and applicable regulations. The role coordinates study visits and specimen handling, maintains study records, supports regulatory submissions and reviews, and works with investigators, participants, sponsors, and internal and external partners to advance studies from preparation through closeout. The coordinator identifies and enrolls participants, conducts pre-consent screening, facilitates informed consent, tracks recruitment and retention, and communicates study-related issues to study leadership. The role also creates and maintains data-collection tools and databases, completes and reviews case report forms and source documentation, performs data-quality checks, addresses data queries, and assists with reporting and analysis. The position may serve as a resource for other clinical research professionals and train new staff.

Requirements

Bachelor’s degree in a related field and at least 1 year of directly related experience, or a master’s degree in a related field.
Knowledge of statistical process control principles.

Responsibilities

Maintain awareness of active studies and arrange study facilities and supplies.
Coordinate study visits and participant and study compliance, including specimen collection, processing, and storage.
Define specimen procedures with the study team; train staff on sample collection, labeling, delivery, processing, and storage.
Maintain required regulatory, study, and participant records and files.
Collaborate with investigators and coworkers to support study progress and completion; serve as a resource for clinical research professionals and train new staff.
Prepare, submit, and maintain regulatory submissions, including new studies, annual reviews, amendments, and adverse events.
Self-audit records and prepare for and participate in monitor visits, audits, and quality reviews.
Coordinate protocol review, approvals, additional regulatory requirements, and study closeout.
Apply legal, regulatory, and policy requirements to promote ethical research and maintain accurate documentation of regulatory activities.
Identify potential participants, conduct pre-consent screening, facilitate informed consent, and document participants approached, screened, and enrolled.
Track recruitment and retention, report progress, communicate challenges, and recommend improvements to study leadership.
Communicate with participants, their clinical teams, investigators, sponsors, study teams, regulatory agencies, and other internal and external organizations.
Compose, organize, and maintain study correspondence; follow through on questions and issues arising during study conduct.
Create case report forms in consultation with team members and complete CRFs and source documentation in accordance with applicable guidelines.
Review CRFs and source documentation for completeness, accuracy, and compliance with Good Clinical Practice.
Enter or oversee data entry into auditable databases or electronic data-capture systems; perform validation, data cleaning, and quality checks.
Address data queries, review reports, tables, and listings, assist with data analysis, and maintain study databases, records, and data storage.
Prepare reports from validation studies of clinical research projects.