Regulatory Affairs Coordinator

POSITION: Regulatory Affairs Coordinator

LOCATION: OHC Blue Ash

HOURS: 40

OHC is currently hiring for a Regulatory Affairs Coordinator to work with our Research / Clinical Trials Team. This position will be based out of our Blue Ash location, however this is a hybrid position and you will have the opportunity to work from home 1-2 days per week after your first 90 days. The Regulatory Affairs Coordinator is vital to our organization, and you will be supporting the regulatory and administrative activities of clinincal trials for our practice by coordinating and preparing regulatory submissions for new and continuing review of clinical trials. OHC has been fighting cancer on the front lines for more than 40 years. We are now one of the nation's largest independent oncology practices, as well as the region's premier source of treatment for nearly every form of adult cancer and complex blood disorder. At its heart, our approach to cancer care is simple - to surround our patients with everything they need so they can focus on what matters most: beating cancer!

Why choose OHC?

You take care of our patients, so we take care of you. OHC's benefits include:

• 3 Health Insurance Plans to choose from
• 2 Dental and 2 Vision insurance plans
• A company matched 401K plan
• Profit sharing plan for clinical employees
• Competitive salaries
• Company paid short term / long term disability / life insurance
• Paid Holidays
• A generous PTO plan
• Tuition Reimbursement
• Professional Development Program
• Nationwide Discounts at your favorite hotels, resorts and retailers just for being an OHC employee
• Wellness Program
• Yearly merit raises
• Opportunities for advancement

• 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 USOR trials.
• Coordinates the completion of feasibility surveys with appropriate staff including PI, research management and others as needed.

• High school diploma or equivalent required; associates degree or higher is preferred, however we will consider experience in lieu of a college degree.
• Minimum one year of experience in a clinical research regulatory affairs and/or an oncology related field required; 2-4 years of clinical reserach experience preferred
• Experience with Microsoft Office
• Experience working with Sponsor Monitor representatives

Specialized Knowledge/Skills

• Experience working in clinical research / clinical trials is preferred
• Must have excellent communication skills
• Strong ability to multi-task
• Excellent time management skills
• Must have strong interpersonal skills to be able to interact with multiple people on many different levels
• Must have a high level of attention to detail and strong organizational skills
• Must be able to work in a fast paced environment
• Must have experience working with GCP (Good Clinical Practice) and ICH (International Council for Harmonisation) guidelines

Working Conditions

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an

oncology/hematology clinic environment.

Physical Requirements

• Large percent of time performing computer based work is required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.