Clinical Research Coordinator III-1

Primary location: Burnet Campus, Department of Orthopaedics. Full-time day shift position, 40 weekly hours.

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 study team to define specimen collection, processing, and storage procedures.
  • Train others to collect, label, and deliver or process samples according to protocol, manual of operations, SOPs, or other work instructions.
  • Ensure specimens are properly logged, handled, and stored.
  • Maintain all records and files required by regulatory agencies and sponsors.
  • Serve as a resource for other clinical research professionals in conducting clinical trials.
  • Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies.
  • Train new staff in preparation and conduct of clinical trials.
• Regulatory Compliance and Documentation
  • Prepare, submit, and maintain all regulatory submissions (proposed new studies, annual review, amendments, and adverse events) accurately and timely to all collaborative parties.
  • Periodically self-audit records to ensure audit-readiness.
  • Prepare, plan, and participate in all monitor visits, audits, and quality reviews (internal and external) professionally.
  • Oversee the review, correspondence, and approval of human research protocols with all regulatory authorities, including study closeout.
  • Determine which research protocols or issues have additional requirements (e.g., review by additional divisions, regulatory agencies, or consultants) and coordinate the process to meet these requirements.
  • Apply legal, regulatory, and policy parameters to promote ethical practices in research involving human participants and ensure compliance.
  • Document the conduct of each protocol's regulatory activities in appropriate systems.
  • Maintain up-to-date and accurate written and electronic records and files to support clinical research activities.
  • Continuously update knowledge of regulatory requirements.
  • May act on behalf of the PI in communicating with sponsors, other divisions, or institutions to coordinate studies and follow through on issues.
• Recruitment / Enrollment / Retention
  • Determine best methods to identify potential participants for research protocols (advertisements, chart reviews, monitoring of clinic schedules, etc.) and prepare accordingly.
  • Create and maintain a detailed tracking system for participants considered for enrollment.
  • Track progress at regular intervals and report to PI and/or management.
  • Identify potentially eligible participants and conduct pre-consent screening to determine eligibility.
  • Review consent forms with participants and provide time for consideration of study participation.
  • Execute the informed consent process according to GCP and CCHMC procedures and other applicable rules, regulations, and policies.
  • Communicate with participants' clinical teams regarding study participation.
  • Document in applicable systems (tracking, electronic health records, etc.) participants approached, screened, and enrolled in the study.
  • Communicate challenges with recruitment and retention to study leadership and make recommendations for improvement.
  • Engage study staff to assist in identifying and enrolling participants.
  • Proactively identify and monitor barriers to recruitment and problem-solve or innovate to overcome them.
• Communication
  • Compose, document, organize, and maintain all correspondence.
  • Oversee and follow through on questions and issues that arise during study conduct.
  • Serve as CCHMC liaison to internal departments, clinical teams, regulatory agencies, physician's 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 a rapport with study participants.
• Data Management
  • Create Case Report Forms (CRFs) in consultation with other team members, using existing study data to promote efficient data collection and entry.
  • Complete CRFs and source documentation in compliance with all applicable guidelines for human research.
  • Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
  • Review documentation from sources to ensure accuracy.
  • Enter data into various auditable databases or electronic data-capture systems and/or oversee data entry and validation to ensure accuracy and completeness.
  • Perform data cleaning procedures and quality checks to ensure data accuracy.
  • Support the data-management process for clinical research projects, including addressing data queries from data managers, project statisticians, and sponsors.
  • Review reports, tables, and listings.
  • Assist in data analysis and maintain record-keeping and data storage for clinical research studies.
  • Maintain master database files for clinical research protocols.
  • Prepare reports from validation studies of clinical research projects.

Requirements

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

About Us

At Cincinnati Children’s, we come to work with one goal: to make children’s health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose.

• Recognized by U.S. News & World Report as a top 10 best Children’s Hospitals in the nation for more than 15 years.
• Consistently among the top 3 Children’s Hospitals for National Institutes of Health (NIH) funding.
• Recognized as one of America’s Best Large Employers (2025) and America’s Best Employers for New Grads (2025).
• Named one of the nation’s America’s Most Innovative Companies by Fortune.
• A Leading Disability Employer as noted by the National Organization on Disability.
• Magnet® designated for the fourth consecutive time by the American Nurses Credentialing Center (ANCC).
• We embrace innovation—together. We believe in empowering our teams with tools that help us work smarter and care better, supporting responsible use of artificial intelligence to create space for new ideas, better outcomes, and a stronger future.

Pay

Expected starting pay range: $56,784.00 - $62,150.40 annually. Starting 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.