The Senior Regulatory Affairs Specialist will play a pivotal role in supporting a robust portfolio of oncology clinical trials at Cincinnati Children’s, including national cooperative group studies, industry-sponsored protocols, and investigator-initiated research.

JOB RESPONSIBILITIES

• Regulatory Knowledge - Apply a comprehensive understanding of regulations, policies, procedures, and ethical principles, to ensure compliance with regulations and CCHMC policies. May research applicable regulations and make recommendations regarding whether a protocol/practice is subject to regulatory oversight. May apply a comprehensive knowledge of regulations/guidance, policies, procedures, and accreditation standards to ensure that institutional oversight committees execute their required function in compliance with all applicable requirements.

• Practice - Use independent and, when appropriate, collaborative judgment to interpret, analyze, and apply federal regulations; state and local law; and CCHMC policies to promote ethical practices. Work with faculty and teams to develop protocols, consent forms and/or other required documents in a manner that anticipated potential ethical, regulatory, editorial or content issues before, during after submission to the oversight committees or other regulatory agency. Prepare, and submit materials in a timely manner, meeting all deadlines. Effectively write reports supporting regulatory determinations. May plan and present educational programs. Use creative and effective presentation skills.

• Compliance - Work daily in an audit ready manner. Serve as an institutional subject matter expert in assigned area(s) as related to research compliance/oversight or regulatory affairs. Answer questions and problem solve for investigators, faculty, staff, and research support staff. Serve as key resource to provide input, based on knowledge, experience and expertise, on institutional initiatives and programs at the direction of leadership, in order to ensure compliance with applicable federal regulations, state statutes and CCHMC policies, principles, ethical standards and procedures. Submit data to collaborative parties accurately and within a timely manner. Periodically self-audit records to ensure audit-ready. Follow policies and procedures governing the handling of confidential information as defined by Cincinnati Children's mission and applicable laws and regulations. May document, organize, and maintain all correspondence with all relevant groups in audit-ready state in electronic and hard-copy format. May review oversight committee determinations to ensure that all required findings and determination have been made with appropriate supporting justification. May ensure that assigned regulatory/compliance activities are appropriately documented in oversight committee records.

• Teamwork, Collaboration, & Leadership - Lead activities to prepare for audits, surveys, quality reviews, accreditation visits or inspections. May use basic project management and organizational skills to lead divisional/institute initiatives. 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 establishing job requirements and goals; perform duties at the desired level of competency. May prepare, plan, and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner.

• Institutional Support - Represent CCHMC at the regional and national level disseminating best practices. May represent CCHMC in meetings/interactions with national or international regulatory or accreditation agencies.

JOB QUALIFICATIONS

• Bachelor's degree in a related field

• 5+ years of work experience in a related job discipline OR Master's degree and 3 years of work experience in a related job discipline

• Applicable professional certification depending on practice area for internal promotion

• Applicable professional certification required within 18 months for external hire

Primary Location

Remote

Schedule

Full time

Shift

Day (United States of America)

Department

Oncology Department

Employee Status

Regular

FTE

1

Weekly Hours

40

*Expected Starting Pay Range

*Annualized pay may vary based on FTE status

$74,297.60 - $94,744.00

• Medical coverage starting day one of employment. View employee benefits here.

• Competitive retirement plans

• Tuition reimbursement for continuing education

• Expansive employee discount programs through our many community partners

• Shift Differential, Weekend Differential, and Weekend Option Pay Programs for qualified positions

• Support through Employee Resource Groups such as African American Professionals Advisory Council, Asian Cultural and Professional Group, EQUAL - LGBTQA Resource Group, Juntos - Hispanic/Latin Resource Group, Veterans and Military Family Advocacy Network, and Young Professionals (YP) Resource Group

• Physical and mental health wellness programs

• Relocation assistance available for qualified positions

*Benefits may vary based on FTE Status and Position Type

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