Remote Senior Clinical Research Data Coordinator - Dallas, TX

Overview

The US Oncology Network is looking for a full-time Remote Senior Clinical Research Data Coordinator to join our team at Texas Oncology! This is a fully remote position based out of our corporate office in Dallas, Texas.

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 Data coordinator do?

The Data Coordinator, under minimal supervision, is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials. Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers, and participated in required training and education. Responsible for the education and training of clinic staff as well as resource for problem solving of complex issues for the implementation of the research process throughout the clinic; process improvements, SOPs. Compiles and reports protocol activity; accrual data, financial information. Train staff and promote professional development of staff. Resource for creation of SOP's and operational plans. 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:

• Screens potential patients for protocol eligibility.
• Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.
• Coordinates patient care in compliance with protocol requirements.
• Maintains investigational drug accountability and disbursement of investigational drug.
• Oversees the preparation of orders by physicians to assure that protocol compliance is maintained.
• In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
• Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel.
• Oversee subject recruitment and study enrollment goals.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
• May collaborate with Research Site Leader in the study selection process.
• Participates in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite.
• Provide leadership in determining and implementing improvements to policies/processes.
• Serve as a resource to train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans.
• May train staff and promote professional development of staff.
• Responsible for compiling and reporting protocol activity, accrual trends, data entry compliance, and research financial information to practice administration and physicians.

Qualifications

The ideal candidate will have the following background and experience:

• Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
• Minimum seven (7) years experience in a clinical or scientific related discipline required
• Minimum five (5) years of experience of oncology and/or clinical research experience preferred.
• SoCRA or ACRP certification preferred.
• Advanced experience with Microsoft Office Advanced experience with computer data entry nd database management Hazmat/IATA training
• Advanced knowledge of medical terminology (oncology)
• Advanced knowledge of clinical trials, regulatory processed, GCP & SOP concepts

Working Conditions: Environment (Office, warehouse, etc.) - Traditional 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 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. (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.)

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