[Hiring] Clinical Research Data Coordinator II @The US Oncology Network

Role Description

The Data Coordinator, under minimal supervision, is responsible for the collection, coordination, processing and quality control of clinical trial data. Works with clinical staff to meet data entry timelines and communicate any concerns about the data. Coordinates the scheduling of procedures, scans and monitoring and auditing visits. Provides leadership in determining and implementing improvements to policies/processes for the data team. Serves as a resource to train others regarding timely data entry and query resolution, proper conduct of sponsor monitor and audit visits. 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.

Responsibilities

• Extrapolate data from source records into case report forms for all patient visits.
• 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.
• Coordinates monitoring and auditing visits ensuring that all data and queries are entered and resolved in accordance with the USOR and sponsor requirements.
• Utilizes USOR clinical trial management system to access research forms and keep current all applicable patient reporting and tracking functions including the patient billing and research payout and payment tracking.
• Maintains research records in a confidential manner according to practice policies, sponsor confidentiality agreements, HIPAA guidelines and any other applicable regulations.
• Provides leadership in determining and implementing improvements to policies/processes.
• Serves as a resource to train others regarding timely data entry and query resolution, proper conduct of sponsor monitor and audit visits.
• Participates in the training and professional development of other data coordinators.
• Assists with investigational drug accountability process, ordering and maintaining research supplies.
• Schedules patient follow up appointments and/or procedures required to maintain protocol compliance.
• Collecting and processing of specimens, imaging documents and other items required for research purposes.
• Acts as resource for other for training and education of other data coordinators at the site/location.

Qualifications

• High School Diploma required.
• Associates Degree or Bachelor's Degree preferred.
• Minimum three (3) years experience medical office experience (preferably oncology).
• Minimum three (3) years of experience as a data coordinator.
• Experience in clinical research, specifically in oncology preferred.
• SoCRA or ACRP certification preferred.
• Advanced experience with Microsoft Office.
• Advanced experience with computer data entry and database management.
• Hazmat/IATA training.
• Advanced knowledge of medical terminology (oncology).
• Advanced knowledge of clinical trials, regulatory processes, GCP & SOP concepts.

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.