Description

SUBFUNCTION DEFINITION: Ensure CCHMC is meeting all regulatory requirements, policies and procedures. Identifies and mitigates risks.

REPRESENTATIVE 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.

???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.

???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.

Qualifications

EDUCATION/EXPERIENCE

Required:

???Bachelor's degree in a related field
???5-7 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.

Preferred:

Unique Skills: