Research Data Coordinator - Dallas, Tx

About the Role

Under general supervision is responsible for the collection, coordination, processing and quality control of clinical trial data, maintaining research protocol and other research files as applicable. Works with clinical staff to meet data entry timelines and communicate any concerns about the data. Works in compliance with US Oncology Research (USOR) Standard Operating Procedure (SOP), principles of Good Clinical Practice (GCP) and all applicable federal state and local regulations. Supports and adheres to the US Oncology Compliance Program to include the Code of Ethics and Business Standards.

Schedule

• Full-time Monday – Friday from 8:30am-5:00pm
• No weekends, call, or major holidays

Responsibilities

• Extrapolate data from source records into case report forms for all patient visits and ensure timely data submission in accordance with USOR SOPs
• Responsible for resolving queries, communicating concerns or questions about data to clinical staff and or research management
• Utilizes USOR clinical trial management system to access research forms and keep current all applicable patient reporting and tracking functions including but not limited to subject CRF Binders/Folders
• Maintains research records in a confidential manner according to practice policies sponsor confidentiality agreements, HIPAA guidelines and any other applicable regulations
• Actively participates in sponsor monitoring and auditing visits, ensuring that all data and queries are entered and resolved in accordance with USOR and sponsor requirements
• Assist with ordering and maintaining research supplies
• Assist with scheduling patient follow up appointments and/or procedures required to maintain protocol compliance
• Assist with collecting and processing of specimens, imaging documents, and other items required for research purposes

Qualifications

Level I:

• High School Diploma required
• Associates Degree strongly desired; Bachelor's Degree preferred
• This is entry-level, and requires no experience
• Some medical office experience required; preferably oncology

Level II (in addition to Level I requirements):

• Minimum three (3) years medical office experience (preferably oncology)
• Minimum three (3) years as Data Coordinator required
• SoCRA or ACRP certifications preferred

Level Senior (in addition to Level I and II requirements):

• Medical office experience required preferably in oncology
• Medical terminology required
• Minimum seven (7) years as a Data Coordinator required
• SoCRA or ACRP certification preferred

Working Conditions

Traditional office environment. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.

Physical Requirements

Large percent of time performing computer based work is required. 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.