Clinical Research Coordinator II/III - Bone Marrow Transplantation

Location: Cincinnati, OH (United States) | Department: Bone Marrow Transplantation | Shift: Day | Schedule: Full time | Weekly Hours: 40

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 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 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., review by other divisions, agencies, or consultants) 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 best 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 or innovate solutions.
• Communication
  • Compose, document, organize, and maintain all correspondence.
  • Oversee and follow through on questions and issues arising during study conduct.
  • Serve as 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 data-management processes, 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 protocols.
  • Prepare reports from validation studies.

Requirements

• CRC II:
  • High school diploma or equivalent, and 2 years of work experience in a related job discipline.
  • Preferred: Bachelor’s degree in a related field.
• CRC III:
  • Bachelor’s degree in a related field and 1 year of directly related work experience, or a Master’s degree in a related field.

Pay

• CRC II: $24.46 – $26.23/hour
• CRC III: $56,784.00 - $62,150.40 annually

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. If you want to be the best you can be, you can do it at Cincinnati Children’s.

Cincinnati Children's is recognized as:

• A top 10 best Children's Hospital in the nation by U.S. News & World Report for more than 15 years.
• Among the top 3 Children's Hospitals for National Institutes of Health (NIH) funding.
• One of America’s Best Large Employers (2025) and Best Employers for New Grads (2025).
• One of America’s Most Innovative Companies (Fortune).
• A Leading Disability Employer (National Organization on Disability).
• Magnet® designated for the fourth consecutive time by the American Nurses Credentialing Center (ANCC).

We embrace innovation and support the responsible use of artificial intelligence to empower teams, improve outcomes, and create a stronger future.