IRB Specialist II - RI Scientific

10 Nationwide Children's Hospital; United States; On-site; USD 65,000 - 95,000; Full time

Job summary

Nationwide Children's Hospital is seeking an experienced regulatory coordinator to support committees within AWRI. You will manage protocol submissions, ensure compliance with federal, state, and local regulations, and safeguard participant rights and safety.

This role involves coordinating with investigators, tracking submissions, training staff on eTRAC usage, and helping maintain accreditation records. A Bachelor's degree is required, Master's preferred, with three years of regulatory

Qualifications

• Bachelor's degree required; Master's preferred.
• Threeyears of relevant research regulatory experience required.
• Effective communication skills, both written and verbal.
• Ability to work independently and in a team environment.

Responsibilities

• Provide protocol submission technical & administrative support to PIs.
• Coordinate submission, review, and maintenance of regulatory protocols.
• Serve as primary resource for organizational review requirements.
• Track pending applications and advise PIs on status.
• Identify approved protocols and assist with compliance conditions.
• Maintain communication about expirations, delinquent responses, and incomplete submissions.
• Act as super-user for the eTRAC system and support process improvements.
• Provide training to PIs and staff on eTRAC submissions.
• Collaborate to ensure mandatory researcher training is completed.
• Attend meetings, seminars, and workshops; draft minutes and correspondence.
• Issue approval notices based on committee conditions.
• Coordinate filing of accreditation applications and inspections records.

Skills

Analytical thinking

Regulatory knowledge

Verbal and written communication

Team collaboration

MS Office proficiency

Education

Bachelor's Degree

Master's Degree (preferred)

Tools

eTRAC system

Job description

Overview

Job Description Summary: Performs administrative functions within regulatory committees at The Abigail Wexner Research Institute (AWRI). Handles and maintains protocol submissions in a manner consistent with all federal, state, and local regulations. Ensures research activities are conducted in an ethical manner that protects the safety, rights, and welfare of participants.

Essential Functions

• Provides protocol submission related technical & administrative support to Principle Investigators (PIs).
• Coordinates across the organization and with multiple levels of faculty and staff to support the assembly, submission, review, and maintenance of regulatory protocols.
• Serves as the primary resource for investigators regarding the organizational review requirements for research protocols.
• Tracks pending applications and advises PIs on the status of submissions.
• Identifies and tracks approved research protocols, including implementing procedures to assist investigators in complying with conditions imposed by the regulatory committees.
• Maintains communication with PIs regarding approaching expirations of study approvals, delinquent responses, incomplete submissions, and other concerns.
• Serves as super-user for the eTRAC system and contributes to the design and implementation of process improvements and business flow changes.
• Provides training to PIs and staff regarding the use of the eTRAC system to submit new protocols or amend existing protocols.
• Collaborates cross-functionally to ensure that researchers have completed mandatory training.
• Attends and supports meetings, seminars, conferences, and workshops.
• Submits minutes of meetings and drafts correspondence based on committee deliberations.
• Issues approval notices based on conditions imposed by the committee.
• Coordinates filing of institutional accreditation applications.
• Maintains records for inspections.
• Ensure the quality, content, and format of regulatory submissions to state, federal, and international agencies.
• Contributes to the compliance management process and ensures timely completion of non-compliance reporting as required by federal and institutional regulatory agencies.
• Attends regulatory professional meetings and identifies new or modified regulations.

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 individuals 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 their supervision.

Education Requirement

Bachelor's Degree, required. Master's Degree, preferred.

Licensure Requirement

(not specified)

Certifications

Relevant certification, preferred.

Skills

• Ability to analyze and apply Federal, industry regulatory agencies and AWRI's policies.
• Effective verbal and written communication.
• Working knowledge of research terminology.
• Ability to work both independently and in a team-oriented environment, under minimal direction.
• Proficiency with MS Office.

Experience

Threeyears of relevant research regulatory experience, required.

Physical Requirements

• OCCASIONALLY: Bend/twist, Climb stairs/ladder, Lifting / Carrying: 0-10 lbs, Pushing / Pulling: 0-25 lbs, Reaching above shoulder, Squat/kneel, Standing, Walking
• FREQUENTLY: (none specified)
• CONTINUOUSLY: Audible speech, Color vision, Computer skills, Decision Making, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing - Far/near, Sitting
• Additional Physical Requirements performed but not listed above: Ability to multi-task within a demanding environment.

EEO

EOE M/F/Disability/Vet

Company Culture

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 15,000 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.