US Oncology

Overview

Texas Oncology is looking for a Regulatory Affairs Coordinator (Hybird Remote) to join our team! This position will support the Ft Worth, Tx location. Hours are 8:30a-5:00p, Monday-Friday. (30min Lunch break).

Texas Oncology is the largest community oncology provider in the country and has approximately 600+ providers in 220+ sites across Texas and southeastern Oklahoma. Our founders pioneered community-based cancer care because they believed in making the best available cancer care accessible to all communities, allowing people to fight cancer at home with the critical support of family and friends nearby. Our mission is still the same today - at Texas Oncology, we use leading-edge technology and research to deliver high-quality, high-touch, evidence-based cancer care to help our patients achieve “More breakthroughs. More victories.” ® in their fight against cancer. Today, Texas Oncology treats half of all Texans diagnosed with cancer on an annual basis.

Why work for us?

Come join our team that is responsible for helping lead Texas Oncology in treating more patient diagnosed with cancer than any other provider in Texas. We offer our employees a competitive benefits package that includes Medical, Dental, Vision, Life Insurance, Short-term and Long-term disability coverage, a generous PTO program, a 401k plan that comes with a company match, a Wellness program that rewards you practicing a healthy lifestyle, and lots of other great perks such as Tuition Reimbursement, an Employee Assistance program and discounts on some of your favorite retailers.

What does the Regulatory Affairs Coordinator (Hybird Remote) do? (Including but not limited to)

Under minimal is responsible for the research regulatory and administrative activities of clinical trials for the practice. Manages all regulatory processes and procedures. Independently prepares protocol documents that comply with regulatory and institutional requirements. Trains and mentors research staff on all regulatory aspects of clinical research. Leads development and implementation of quality improvement measures. 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

The essential duties and responsibilities (including but not limited to):

• 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. Assists with local QA Initiatives. Leads development and implementation of quality improvement measures to assist Investigators with protocols and regulations.
• As subject matter expert develops and implements training materials to ensure the staff are in compliance and up to date on all Federal, State, and local laws and regulations.
• Oversees the preparation of Informed Consent Documents regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions. Reviews local and central Institutional Review Board submissions. Monitors and 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 information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials.
• Trains and mentors research staff on all regulatory aspects of clinical research.

Qualifications

The ideal candidate for the Regulatory Affairs Coordinator (Hybird Remote) position will have the following background and experience:

• Associate's degree required. Bachelor's degree in a clinical or scientific related discipline preferred.
• Minimum seven 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.

Physical Demands:

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 full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. 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.

Work 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 may occur.