Regulatory Affairs Coordinator

The US Oncology Network•Denver, CO

7d•Hybrid

About The Position

Rocky Mountain Cancer Centers (RMCC), Colorado's largest and most comprehensive provider of cancer care, has an exciting opportunity for an experienced Regulatory Affairs Coordinator in Denver. This position offers a hybrid work schedule, with a requirement to work onsite in the office two days per week. Candidates must reside within the Denver Metro area to support regular in-person collaboration and business needs. The role involves research regulatory and administrative activities of clinical trials, playing an integral part in the regulatory/compliance process for all clinical research conducted. This includes site qualification and management of study regulatory documents throughout the site’s participation. The coordinator will collaborate with research staff and management on process improvement and QA initiatives, and may train other employees on regulatory processes. Ensuring site research quality involves 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 position also supports and adheres to the US Oncology Compliance Program, including the Code of Ethics Business Standards.

Requirements

Associate's degree required.
Minimum seven 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.
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.
All qualified candidates are required to pass a background check prior and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire.

Nice To Haves

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

Responsibilities

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.
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.