Regulatory Project Coordinator - Regulatory Affairs Administration

The Regulatory Project Coordinator coordinates the processing, reporting, and special projects for the Office of Research Regulatory Affairs. This position is responsible for maintaining relevant records through the database, and preparing reports on FDA-regulated clinical trial activity. This position is also responsible for interactions with external clients (project management, billing, etc.).

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

PRINCIPAL DUTIES AND RESPONSIBILITIES

Maintains compliant records of FDA submissions.

Creates and maintains a database of active and historical clinical trials and FDA-regulated research programs.

Develop a thorough knowledge of Regulatory Affairs.

Tracks and takes leadership of annual reporting for INDs and IDEs.

Coordinates financial matters for the office including accounts payable and billing of external clients. Assists department in maintaining cost center information and fiscal tracking and monitoring of budgets and expenditure reports.

Liaison with external clients, coordinates intake and scope-of-work assessment.

Assists Regulatory team in document creation and submission.

Prepares relevant reports on AWRINCH regulated-research metrics.

Provide project management for novel clinical trial programs.

All other duties as assigned.

Qualifications

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

Four year degree preferred; Experience with investigator-initiated drug and device activities preferred.

Proven project management skills.

Good organizational, confidentiality, and written and verbal communication skills.

Strong knowledge of Microsoft Office and Adobe Acrobat.

Analytical/critical thinking skills.

Ability to work on several tasks simultaneously.

Minimum Physical Requirements:

Note frequency as Constantly (67-100%), Frequently (34-66%) and Occasionally (0-33%) for each requirement. Also note any lifting requirements with pound limit. Typing on computer Constantly (67-100%) Using phone Constantly (67-100%) Sitting Constantly (67-100%) Standing Occasionally (0-33%) Lifting Occasionally (0-33%) Walking Occasionally (0-33%)

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

Full Time