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.

• 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.

Minimum Job Qualifications (Knowledge, Skills, & Abilities):

Education/Training -

• High School Diploma required
• Associates Degree strongly desired; Bachelor's Degree preferred
• 0-3 Years work experience
• Some medical office experience required; preferably oncology

Business Experience -

• Experience in Microsoft Office
• Experience with computer data entry and database management
• Experience in clinical research desired
• High computer literacy required

Specialized Knowledge/Skills -

• Excellent written and oral communication skills
• Excellent multi-tasking skills
• High attention to detail and accuracy
• Ability to independently organize, prioritize, and make decisions
• Knowledgeable of medical terminology

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.)