Overview
Texas Oncology is looking for
Remote Research Regulatory Affairs Coordinator II to join our team! This position will work and support
The Woodlands, Texas location.
The Woodlands has been ranked No. 1 best city to live for two years in a row by Niche’s annual rankings. The Woodlands is known for its appeal to family life, highly rated public schools, urban living, shopping, dining, entertainment venues and recreational trails along the waterway and town center. Our management team values an approach of teamwork and collaboration to provide high-quality, individualized care for each patient we serve.
Texas Oncology is the largest community oncology provider in the country and has approximately 600+ providers in 280+ 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 patients 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 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.
Responsibilities
The essential duties and responsibilities:
- Coordinates Critical Document Collection to facilitate the timely opening of trials at the site.
- Communicates and collaborates with central operations to identify and resolve any regulatory issues.
- Maintains Protocol Regulatory Documents in compliance with local Standard Operating Procedures.
- Reviews Investigator files and verifies all regulatory documents are filed in accordance with federal, state, and local regulations.
- Assists with scheduling for monitoring visits, study start up visits, close out visits, and audits as needed.
- Communicates issues with regulatory documents or procedures to clinical staff, research management, and investigators.
- Assists the 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.
- Coordinates local and central Institutional Review Board submissions.
- Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents.
- Coordinates the completion of feasibility surveys with appropriate staff including PI, research management and others as needed.
- May compile information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials.
Qualifications
The ideal candidate for this position will have the following background and experience:
- High school diploma or equivalent required; some college coursework or other relevant background preferred
- Minimum three (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 preferred.
- Must have excellent communication skills, strong ability to multi-task, excellent time management skills.
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.
