Regulatory Affairs Coordinator II

The US Oncology Network•Salem, VA

6d•Onsite

About The Position

Under minimal supervision, this role is responsible for the research regulatory and administrative activities of clinical trials for the practice. The position plays an integral role in the regulatory/compliance process of all clinical research conducted, including site qualification and management of study regulatory documents throughout the site’s participation. This role collaborates with research staff and management on process improvement and QA initiatives and may train other employees on regulatory processes. The position 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. The role supports and adheres to the US Oncology Compliance Program, including the Code of Ethics Business Standards.

Requirements

High School Diploma required.
Minimum 3 years of experience in clinical research, regulatory affairs and/or an oncology related field required.
Experience in Microsoft Office
Experience working with Sponsor Monitor representatives.
Excellent communication skills
Strong ability to multi-task
Excellent time management skills
Strong interpersonal skills to be able to interact with multiple people on many different levels.
High level of attention to detail
Able to work in a fast paced environment

Nice To Haves

Associate's degree in a clinical or scientific related discipline preferred.
Experience working in clinical research is preferred

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 information 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.