Regulatory Affairs Coordinator II-San Antonio, Tx

US Oncology, Inc.•San Antonio, TX

54d•Onsite

About The Position

Texas Oncology is looking for a Regulatory Affairs Coordinator to join our team! This position will support the San Antonio, Tx location. Hours are 8:30a-5:00p, Monday-Friday. 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. 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 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.

Requirements

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.
Experience in Microsoft Office
Experience working with Sponsor Monitor representatives.
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

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 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.