Regulatory Affairs Coordinator

Ohc - Cincinnati, OH

Full-time

Remote - Cincinnati, OH

Motor Vehicle and Parts Dealers

About the position

The Regulatory Affairs Coordinator plays a crucial role in supporting the regulatory and administrative activities of clinical trials at OHC. This position involves coordinating and preparing regulatory submissions for new and ongoing clinical trials, ensuring compliance with federal, state, and local regulations. The role is hybrid, allowing for some remote work after an initial training period.

Responsibilities

• Coordinates Critical Document Collection to facilitate the timely opening of trials at the site.
• Maintains Protocol Regulatory Documents in compliance with local and US Oncology Standard Operating Procedures.
• Reviews Investigator files and verifies all regulatory documents are filed in accordance with federal, state, and local regulations.
• Assists with scheduling for monitoring visits, study start up visits, close out visits, and audits as needed.
• Communicates issues with regulatory documents or procedures to clinical staff, research management, and investigators.
• Assists with preparation of Informed Consent Documents and creates regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions.
• Coordinates local and central Institutional Review Board submissions.
• Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents.
• May compile information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for US OR trials.
• Coordinates the completion of feasibility surveys with appropriate staff including PI, research management and others as needed.

Requirements

• High school diploma or equivalent required; associates degree or higher is preferred.
• Minimum one year of experience in a clinical research regulatory affairs and/or an oncology related field required; 2-4 years of clinical research experience preferred.
• Experience with Microsoft Office.
• Experience working with Sponsor Monitor representatives.
• Experience working in clinical research / clinical trials is preferred.
• Excellent communication skills.
• Strong ability to multi-task.
• Excellent time management skills.
• Strong interpersonal skills to interact with multiple people on many different levels.
• High level of attention to detail and strong organizational skills.
• Ability to work in a fast-paced environment.
• Experience working with GCP (Good Clinical Practice) and ICH (International Council for Harmonisation) guidelines.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Health insurance
• Life insurance
• Opportunities for advancement
• Paid Holidays
• Generous PTO plan
• Tuition Reimbursement
• Professional Development Program
• Wellness Program
• Yearly merit raises