Regulatory Affairs Specialist - Bone Marrow Transplantation

Job Responsibilities

• Protocol - Apply a comprehensive understanding of research regulations, ethics and guidelines, analyze research protocols submissions (new protocols, continuing review, changes to protocols, one-time use request and adverse events) to determine compliance with regulations. Oversee the review and correspondence of research protocols. Use independent judgment to interpret, analyze, and apply federal, state and CCHMC guidelines to promote ethical practices in research involving human subjects and to ensure compliance to those regulations by faculty and staff investigators. Work directly with individual faculty and staff investigators and research support staff to address human subjects issues during protocol review. Answer questions and problem solve for investigators, faculty, staff, research coordinators and students. Act as a liaison between IRB members and researchers to promote information flow. Prepare, review and submit all protocol amendments, SAE reports, and continuing reviews. Complete all reviews and submissions in a timely manner, meeting all deadlines. Under the guidance of senior staff, may assist in the development of protocol documents including but not limited to the protocol and consent forms.
• Compliance - Upon request from investigators, conduct pre-reviews of draft documents (such as new protocol submissions, exemptions, and changes of protocol) and advise investigators and research coordinators regarding potential ethical, regulatory, editorial or content issues before they are submitted for full IRB review. Determine which research protocols or issues have additional requirements, such as the need for review by an outside expert, and coordinate the process to meet these requirements. Follow policies and procedures governing the handling of confidential information as defined by Cincinnati Children's mission and applicable laws and regulations. Review timeliness, accuracy, availability and security of information.
• Process - Work daily in an audit ready manner. Organize and participate in activities to prepare for audits, surveys, quality reviews, and inspections. Participate in improving organizational performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and providing input to department discussions. Participate in staff committee, subcommittee, or special project groups. This may include research and writing, coordinating meeting schedules, preparing and distributing materials, recording minutes to document progress, and communicating the final outcome. By applying a comprehensive understanding of research and ethics, compose clear and precise memos, reports and training materials. Assist in developing written guidelines and educational materials for investigators (faculty and staff). Contribute to planning and presenting educational programs for investigators, research coordinators, and other groups. Use creative and effective presentation skills. Participate in establishing job requirements and goals; perform duties at the desired level of competency.
• Procedure - Act as a resource for faculty and staff regarding regulations during research protocol review. Serve as an informational and referral resource for the research community regarding regulatory, ethical and procedural issues. Maintain currency in field through cross-training, continuing education, literature and seminars. Implement this knowledge into the department.
• Documentation - Document the conduct of each protocol's regulatory activities in an electronic regulatory system.. Maintain written and electronic systems to support the clinical research activities. Submit data to collaborative parties accurately and within a timely manner.
  
  

Job Qualifications

• Bachelor's degree in a related field
• 2 years of work experience in a related job discipline
  
  

Primary Location

Burnet Campus

Schedule

Full time

Shift

Day (United States of America)

Department

Bone Marrow Transplantation

Employee Status

Regular

FTE

1

Weekly Hours

40

• Expected Starting Pay Range
• Annualized pay may vary based on FTE status $56,846.40 - $72,488.00
  
  

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 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), America’s Best Employers for New Grads (2025)
• One of the nation's America’s Most Innovative Companies as noted by Fortune
• Consistently certified as great place to work
• 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 the tools that help us work smarter and care better. That’s why we support the responsible use of artificial intelligence. By encouraging innovation, we’re creating space for new ideas, better outcomes, and a stronger future—for all of us.

Comprehensive Job Description Provided Upon Request.

Cincinnati Children’s is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability