Regulatory Affairs Coordinator II

Overview

Under minimal supervision is responsible for the research regulatory and administrative activities of clinical trials for the practice. Plays an integral role in the regulatory/compliance process of all clinical research conducted to include site qualification, and management of the study regulatory documents throughout the site’s participation. Collaborates with research staff and management on process improvement and QA initiatives. May train other employees on regulatory process. Ensures 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

Job Description

Key Responsibilities

• In collaboration with investigators, responsible for tracking and completing protocol feasibility questionnaires. Coordinates Critical Document Collection to facilitate the timely opening of trials at the site. Communicates and collaborates with central operations and data management to identify and resolve any regulatory issues.
• Maintains Protocol Regulatory Documents in compliance with local and US Oncology Standard Operating Procedures.
• Coordinates scheduling and set up for audits and all Monitor, study start-up, and close out visits. Responsible for communication of any regulatory issues noted at visits to appropriate clinical staff, management or investigators.
• Prepares Informed Consent Documents and creates regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions. Coordinates local and central Institutional Review Board submissions. Reports SAEs to sponsor/FDA/IRB.
• Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents. Actively participates in study initiations and study specific educational programs. Compiles and monitors infor-
• mation necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials.
• Acting as a subject matter expert may orient/train other staff in regulatory process.
• Collaborates with research staff and management on process improvement and QA initiative.
  
  

Qualifications

Education/Training –

• High School Diploma required. Associate's degree in a clinical or scientific related discipline preferred.
• Minimum 3 years of experience in 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.) –

• 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.
  
  

Salary Scale: The general pay scale for this position at BRCC is $23.00-35.39 The actual hiring rate is dependent on many factors, including but not limited to prior work experience, education, job/position responsibilities, location, work performance, etc.