OPRN Multi-Site Regulatory & Compliance Specialist

Overview

The OPRN Compliance and Regulatory Specialist will provide day to day oversight of all regulatory aspects of OPRN Multisite Investigator Initiated Studies (IIS); overseeing the IRB/regulatory and reliance processes to ensure compliance with all local policies and procedures as well as site-specific considerations. The position requires an in-depth, working knowledge of federal regulations including U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), Department Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practices (ICH GCP), IRB and institutional policies, as well as an ability to discern critical pieces of information in study protocols and an in-depth knowledge of the day to day clinical research process.

Why Nationwide Children's Hospital?

The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children’s Hospital, Where Passion Meets Purpose.

Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission.

We’re 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we’ll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.

Ask anyone with a Nationwide Children’s badge what they do for a living. They’ll tell you it’s More Than a Job. It’s a calling. It’s a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.

Nationwide Children’s Hospital. A Place to Be Proud.

Responsibilities

Essential Job Functions: 

• Supervises the overall regulatory process under the direction of Clinical Research Project Managers for OPRN Multi Site IIS projects; identifying areas of risk and assisting with developing processes to address deficiencies; creates new processes to improve efficiencies and/or respond to system changes.
• Responsible for communication with NCH IRB, study sites, and Data Coordinating Center, as appropriate, to create and maintain the Regulatory Essential Documents List and eTMF guide, creates and implements training materials for engaged study sites for IIS reliance regulatory process. 
• Participates in site assessment visits in conjunction with Clinical Research Project Manager.
• Participates in internal and site-specific feasibility assessment discussions, identify protocol content which may conflict with federal and/or local requirements or practice or may cause challenge for site implementation. 
• Reviews study protocols in order to facilitate accurate IRB submission, interaction with sponsors, management of the IRB and regulatory processes within the regulatory team both internally and externally via the iREX reliance system. 
• Manages the development and implementation of clinical research education training in conjunction with the Clinical Research Project Manager for site continuing education and study regulatory integrity. 
• Identifies additional training and Quality Improvement Program needs within study sites; makes recommendations to OPRN study leadership; implements new programs as approved. 
• Design and implement site-facing QA/QC programs and collect metrics. 
• Ensures the annual QA/QC metrics are reported to OPRN IIS study leadership; assists with the identification of new metrics as needed.
• Serves as liaison between study sponsors and the research team (IRB, research staff and Principal Investigator) regarding regulatory matters in the study management process. 
• Maintains current knowledge of federal, local and institutional research regulations by reviewing current publications and attending conferences; Advises OPRN IIS management of regulation changes and projected impact.
• Creates and delivers internal and external presentations on clinical research regulatory topics. 
• Takes opportunities to provide leadership within the team through communicating effectively, mentoring, valuing, and building on diversity and differences within the team, building and maintaining relationships, and assisting in ensuring effective and compliant teams and work groups. 
• Attends both regular and study staff meetings to provide updates. 
• If needed, collaborates in the grant writing process and submission from a regulatory perspective.

Qualifications

Knowledge, Skills & Abilities:

Education Requirement: BA degree or equivalent experience in medical/science field.

Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Administrators or able to obtain within 6 months of hire

Skills:

• Supervisory experience preferred.
• Strong organizational skills 
• Exceptional interpersonal skills
• Excellent written and verbal communication. 
• Detailed orientated. 
• Demonstrated, in-depth working knowledge of IRB and Regulatory systems. 
• Proven track record working with diverse functional areas; ability to multi-task; strong organization skills; detail oriented; customer-focused personality; “get it done” attitude. 
• Self-starter that can quickly react to rapidly emerging and changing business needs; works well independently and within teams.

Experience: Two years of Clinical Research experience required, 5 years preferred.

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

EOE M/F/Disability/Vet