Data Coordinator, Sr
Roanoke , VA
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Posted 5 days ago
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Job Description
Overview
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.
• Provide leadership in determining and implementing improvements to policies/processes.
• Serve 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.
• Schedule and conduct site facility tours and inspections. Facilitate PI and Sub-I signatures on case report forms. Facilitate staff access to study systems.
• Collection and processing of specimens, imaging documents, and other items required for research purposes.
• Ordering and maintaining research supplies.
• Assists manager in coordinating staff assignments and work schedules as needed.
Qualifications
High School Diploma required Associates Degree strongly desired: Bachelor's Degree preferred Medical office experience required preferably in oncology Medical terminology required Minimum 7 years as a Data Coordinator required. SoCRA or ACRP certification preferred Business Experience - Excellent leadership skills Experience in clinical research required Advanced experience with computer data entry and database management Excellent written and oral communication skills Excellent organizational skills Attention to details and accuracy Ability to lead the team and work independently, organized, prioritize, and follow through with results Specialized Knowledge/Skills - Advanced knowledge of medical terminology (oncology) Able to interpret diagnostic imaging, pathology, hematology, oncology related reports Clinical trials and regulatory processes GCP and SOP concepts Hazmat/IATA training
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 Requirement s (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.)
The US Oncology Network is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
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Job Summary
Company
US Oncology Network-wide Career Opportunities
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
Open