Regulatory Affairs Coordinator

The US Oncology Network is looking for a Remote Research Regulatory Affairs Coordinator II to join our team at Texas Oncology! This position is based out of our corporate office in Dallas, Texas and will support all TxO Locations.

As a part of The US Oncology Network, Texas Oncology delivers high-quality, evidence-based care to patients close to home. Texas Oncology is the largest community oncology provider in the country and has approximately 600+ providers in 280+ sites across Texas, 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, 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.

The US Oncology Network is one of the nation's largest networks of community-based oncology physicians dedicated to advancing cancer care in America. The US Oncology Network is supported by McKesson Corporation focused on empowering a vibrant and sustainable community patient care delivery system to advance the science, technology, and quality of care.

What does the Remote Research Regulatory Affairs Coordinator do?

This position, under minimal supervision, 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. Leads development and implementation of quality improvement measures. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) and Texas Oncology Research Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPAA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

The essential duties and responsibilities:

• Assists with Critical Document collection and maintenance to facilitate the timely opening of trials at the site and audit-readiness through the life of the study.
• Communicates and collaborates with central operations to identify and resolve any regulatory issues.
• Maintains Protocol Regulatory Documents in compliance with local Standard Operating Procedures.
• Maintains Texas Oncology Research systems, including ensuring appropriate access to all staff and sponsor representatives and troubleshooting any issues
• Assists with local QA Initiatives. Leads development and implementation of quality improvement measures to assist Investigators with protocols and regulations.
• Assists with preparation of Informed Consent Documents and regulatory packets (FDA1572, Financial Disclosures, etc.) for sponsor and IRB submissions.
• Processes local and central Institutional Review Board submissions.
• Monitors and reports SAEs to sponsor/IRB.
• Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents.

The ideal candidate for the position will have the following background and experience:

Level 1 qualifications

• High school diploma or equivalent required; some college coursework or other relevant background preferred.
• Minimum one year of experience in a clinical research regulatory affairs and/or an oncology related field required.

Level 2 (in addition to level 1 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.

Level Sr (in addition to level 1 and 2 requirements)

• 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

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. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)