Regulatory Affairs Coordinator II

US Oncology Network-wide Career Opportunities; Salem (VA); On-site; USD 32,000 - 49,000; Full time

Job summary

US Oncology Research, Inc. (USOR) seeks a Regulatory Specialist to oversee research regulatory and administrative activities for clinical trials. This role supports SOPs, GCP, and applicable regulations, coordinating site qualification and regulatory document management to ensure quality.

You will train staff, collaborate on process improvements, and ensure timely regulatory submissions and QA initiatives across trial sites, in a fast-paced outpatient environment.

Qualifications

• High School Diploma required; an Associate's degree in a clinical or scientific-related discipline is preferred.
• Minimum 3 years of experience in clinical research, regulatory affairs and/or an oncology-related field is required.

Responsibilities

• Track and complete protocol feasibility questionnaires; coordinate critical document collection to facilitate timely opening of trials.
• Maintain Protocol Regulatory Documents in compliance with SOPs.
• Coordinate scheduling and setup for audits and monitor, start-up, and close-out visits; communicate regulatory issues to staff.
• Prepare Informed Consent Documents and regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions; coordinate IRB submissions.
• Facilitate collection of site training documents and participate in study initiations and educational programs; monitor information for continuing review by IRB or Network PI.
• Provide SME guidance; orient/train other staff in regulatory processes.
• Collaborate with research staff and management on process improvement and QA initiatives.

Skills

communication skills

multitasking

time management

interpersonal skills

attention to detail

fast-paced environment

Microsoft Office

sponsor monitors

Education

High School Diploma

Associate's degree in clinical or scientific field preferred

Tools

Microsoft Office

Job description

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

• 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.