Clinical Research Coordinator III - Infectious Diseases

Primary Location: Winslow Research Pavilion, Department of Infectious Diseases. Full-time position (40 weekly hours, 1.0 FTE) with a rotating shift.

Responsibilities

• Study Conduct / Clinical Research Practice
  • Maintain awareness of status of all active studies.
  • Arrange for facilities and supplies.
  • Ensure participant and study compliance, including collection of study specimens and study visits.
  • Work with the study team to define specimen collection, processing, and storage procedures.
  • Train others to collect, label, and process samples according to protocol, manual of operations, or SOPs.
  • Ensure specimens are properly logged, handled, and stored.
  • Maintain records and files required by regulatory agencies and sponsors.
  • Serve as a resource for clinical research professionals in conducting clinical trials.
  • Collaborate with investigators and coworkers to ensure proper progress and completion of studies.
  • Train new staff in preparation and conduct of clinical trials.
• Regulatory Compliance and Documentation
  • Prepare, submit, and maintain all regulatory submissions (new studies, annual reviews, amendments, adverse events) accurately and timely.
  • Periodically self-audit records to ensure audit-readiness.
  • Prepare, plan, and participate in monitor visits, audits, and quality reviews.
  • Oversee review, correspondence, and approval of human research protocols with regulatory authorities, including study closeout.
  • Determine additional protocol requirements (e.g., reviews by additional divisions or agencies) and coordinate processes.
  • Apply legal, regulatory, and policy parameters to promote ethical research practices and compliance.
  • Document regulatory activities in appropriate systems.
  • Maintain up-to-date and accurate written and electronic records.
  • Continuously update knowledge of regulatory requirements.
  • Act on behalf of the Principal Investigator (PI) in communications with sponsors, divisions, or institutions.
• Recruitment / Enrollment / Retention
  • Determine methods to identify potential participants (advertisements, chart reviews, clinic schedules).
  • Create and maintain a detailed tracking system for participants considered for enrollment.
  • Track progress at regular intervals and report to PI or management.
  • Identify potentially eligible participants and conduct pre-consent screening.
  • Review consent forms with participants and execute the informed consent process according to GCP and institutional procedures.
  • Communicate with participants' clinical teams regarding study participation.
  • Document participants approached, screened, and enrolled in applicable systems.
  • Communicate recruitment and retention challenges to study leadership and make improvement recommendations.
  • Engage study staff to assist in identifying and enrolling participants.
  • Proactively identify and monitor barriers to recruitment and problem-solve to overcome them.
• Communication
  • Compose, document, organize, and maintain all correspondence.
  • Oversee and follow through on questions and issues arising during study conduct.
  • Serve as the liaison to internal departments, clinical teams, regulatory agencies, physician offices, city clinics, government agencies, academic centers, and other organizations.
  • Communicate study-related issues to investigators, sponsors, coordinating centers, study coordinators, clinical and research teams, managers, and other institutions.
  • Develop rapport with study participants.
• Data Management
  • Create Case Report Forms (CRFs) in consultation with team members to promote efficient data collection.
  • Complete CRFs and source documentation in compliance with applicable guidelines.
  • Review CRFs for completeness, accuracy, and compliance with Good Clinical Practice.
  • Review documentation from sources to ensure accuracy.
  • Enter data into auditable databases or electronic data-capture systems and oversee data entry and validation.
  • Perform data cleaning procedures and quality checks.
  • Support the data-management process, including addressing data queries from data managers, statisticians, and sponsors.
  • Review reports, tables, and listings.
  • Assist in data analysis and maintain record-keeping and data storage for studies.
  • Maintain master database files for clinical research protocols.
  • Prepare reports from validation studies.

Requirements

• Bachelor’s degree in a related field OR Master’s degree in a related field.
• 1+ years of directly related experience (waived for Master’s degree holders).
• Knowledge of statistical process control principles.

About Us

At Cincinnati Children’s, we focus on improving children’s health through a holistic team approach in patient care and scientific advancement. We strive for excellence and find inspiration in our shared purpose. Recognitions include:

• Top 10 best Children’s Hospitals in the nation for over 15 years (U.S. News & World Report).
• Consistently among the top 3 Children’s Hospitals for NIH funding.
• Recognized as one of America’s Best Large Employers (2025) and Best Employers for New Grads (2025).
• Named among America’s Most Innovative Companies (Fortune).
• A Leading Disability Employer (National Organization on Disability).
• Magnet® designated for the fourth consecutive time (ANCC).

We embrace innovation, including the responsible use of artificial intelligence, to empower teams and improve outcomes.

Pay

Expected starting pay range: $56,784.00 - $62,150.40 annually. Pay is based on experience, skills, and equity; exceptions may apply for highly qualified candidates. Additional pay (e.g., shift, on-call, or weekend differentials) and benefits may apply. Annual pay may vary based on FTE status.