Research Regulatory Affairs Coordinator

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Research Regulatory Affairs Coordinator

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• Las Vegas, Nevada
• Research
• Comprehensive Cancer Centers of Nevada
• 34007
  
  

Overview

Job Description

Comprehensive Cancer Centers of Nevada (CCCN) is dedicated to advancing cancer care by leading and participating in many clinical research studies in Nevada that test the safety and efficiency of new or modified treatments in cancer patients. These trials are important because they help uncover new treatment options and give many of our patients the opportunity to receive newly developed treatments or investigational drugs not yet available outside the study.

CCCN develops and conducts more than 170 Phase I, Phase II and Phase III clinical research trials each year including genitourinary and gastrointestinal cancer treatments, radiation clinical trials, breast cancer and skin cancer. Motivated, caring professionals are encouraged to join us.

Career Opportunity

Comprehensive Cancer Centers of Nevada has an exciting opportunity for a Regulatory Affairs Coordinator at our Central Business office in Henderson, Nevada.

Scope

Under general supervision is responsible for supporting the regulatory team with coordinating the research regulatory and administrative activities of clinical trials for the practice. Coordinates the preparation of regulatory submissions for new and continuing review of clinical trials. Works closely with US Oncology Regulatory and Sponsors in coordination of study start-up and closure procedures. Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

Responsibilities

ESSENTIAL DUTIES AND 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

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent required; some college coursework or other relevant background preferred
• Minimum one year of experience in a clinical research regulatory affairs and/or an oncology related field required
  
  

Business Experience -

• Experience in Microsoft Office
• Experience working with Sponsor Monitor representatives
  
  

Specialized Knowledge/Skills -

• Experience working in clinical research 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
• Must be able to work in a fast-paced environment
  
  

Working Conditions

Environment (Office, warehouse, etc.) –

Traditional outpatient clinic/office environment. 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 (Lifting, Standing, Etc.) –

A large percentage 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.

Successful candidates will thrive in a fast paced, rapidly changing environment and have a passion for caring for their patients.

Ready For Your Next Career Challenge? We’d Love to Hear from You!

If you possess the above qualifications and a desire to make a difference, we invite you to submit your resume and apply. In addition to a great career opportunity, we offer excellent benefits, a team environment, professional development, and the chance to be part of a nationwide network dedicated to fighting the war against cancer. To apply please click on the “Apply” link.

The US Oncology Network is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status. This employer participates in E-Verify.

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