What are the responsibilities and job description for the Research Quality Assurance Medical Auditor position at Nationwide Children's Hospital?
Overview
The Clinical Research Quality Assurance Auditor will work within the Office of Research Compliance and Integrity to conduct internal audits on clinical trials and research billing activity to ensure compliance with federal, state, and local regulations and internal policies and guidelines. Written reports and oral presentations of audit findings will be completed, presented to the Principal Investigator and Team, and action items followed to resolution. Train Study Team Staff on identified clinical trial compliance issues as needed.
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
1. Conduct audits of clinical trial data and records, investigator sites, monitoring files, and study files to ensure accuracy and compliance with applicable regulations.
2. Review clinical trial data such as case report forms and subject medical records, and other relevant files to monitor compliance with protocols.
3. Prepare written audit reports including a corrective action plan.
4. Follow-up audit findings to an appropriate resolution.
5. Provide support during external investigations of clinical research (government and/or industry) as requested.
6. Audit clinical trial billing to detect potential fraud or inconsistent business practices.
7. Identify compliance education needs and assist in the research education program.
8. Maintain a current knowledge base of all applicable research regulations.
9. Assist Senior GCP Auditor on executing Annual Compliance Work plan
9. Other duties as assigned.
Qualifications
Education Requirement: Bachelor's Degree in a health science or related field, or equivalent experience, required. Experience: • Three years of clinical research experience, required. • Two years of quality assurance experience with human subject research, preferred.
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
