Regulatory Affairs Coordinator - Oncology Hematology Care, Inc.
Cincinnati, OH
About the Job
Overview
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
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 USOR trials.
Coordinates the completion of feasibility surveys with appropriate staff including PI, research management and others as needed.
Qualifications
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 Practi
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
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 USOR trials.
Coordinates the completion of feasibility surveys with appropriate staff including PI, research management and others as needed.
Qualifications
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 Practi
Source : Oncology Hematology Care, Inc.
