Coordinator, Research Data - Leukemia

Coordinator, Research Data – Leukemia

The primary purpose of the Coordinator, Research Data is to provide administrative and patient care services for the coordination of clinical research studies. The Coordinator, Research Data position within the Leukemia Department plays a key role in supporting the successful execution of clinical research studies. This role is essential in ensuring accurate data management, smooth coordination of regulatory and administrative processes, and consistent communication across research teams, investigators, and external sponsors. The ideal candidate is detail oriented, highly organized, and motivated to contribute to meaningful clinical research efforts that advance patient care and scientific discovery.

The ideal candidate is a highly organized and detail oriented professional who can efficiently manage clinical research data, navigate regulatory processes, and communicate clearly with investigators, sponsors, and internal teams while supporting leukemia research studies.

Salary Range –
Minimum Salary: 44,000 | Midpoint Salary: 55,000 | Salary Maximum: 66,000
 

MD Anderson offers our employees:

Paid employee medical benefits (zero premium) starting on first day for employees who work 30 or more hours per week
Group Dental, Vision, Life, AD&D and Disability coverage
Paid time off (PTO) and Extended Illness Bank (EIB) paid leave accruals
Paid institutional holidays, wellness leave, childcare leave, and other paid leave programs
Tuition Assistance Program after six months of service
Teachers Retirement System defined-benefit pension plan and two voluntary retirement plans
Employer paid life, AD&D and an illness-related reduced salary pay program
Extensive wellness, recognition, fitness, employee health programs and employee resource groups

KEY FUNCTIONS
Coordination of Administration of Clinical Trials
• Assists in the coordination and administration of regulatory correspondence for departmental clinical research protocols
• Assists in the implementation of databases to improve departmental protocol workflow for new protocols and protocol amendments
• Completes protocol visit profiles in Prometheus for LCRS visits
• Maintains and updates database for protocols, related grants and protocol reference materials
• Tracks all revisions to protocols and notify research staff of changes made to a protocol for departmental training
• Maintains the Leukemia Department Protocol Priorities by interacting with the section chiefs of the Leukemia subtypes to keep the protocol priority list current
• Maintains the active protocol files for clinical research staff, uploading electronic copies to the department’s intranet website
• Update and maintain all active Leukemia protocols available to the public on www.mdanderson.org
• Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., Surveillance Committee) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration)
• Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination
• Coordinates and sends outgoing material and correspondence to institutional, state, and/or federal agencies
 

Data Management Organization and Analysis of Clinical Research Information
• Prepares scheduled status reports describing interim data
• Provides clinical trial information and patient information in a database to aid with departmental projects
• Prepares reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually)
• Report periodically on protocol activity for department and division use
• Enters all labs for IND exempt and IND studies in PDMS
• Monitors and completes all requests for scheduling of pharmaceutical sponsors and IND monitoring visits
• Reviews and triages labs from outside physician offices on IND studies when needed
• Provides coverage for other coordinators by assisting with responsibilities and activities within the coordinators’ office in accordance with individual strengths and expertise
• Informs appropriate staff and arrange coverage for necessary functions when absent
 

LCRS
• Review all LCRS appointments requested in Quickbase and schedule all upcoming appointment requests in EPIC. Provide a continuous query of missing lab manuals and other needed material, including follow up with sponsors. Continuously look for missing lab manual and other material to ensure it is part of the protocol folder.
• Assist Draw Sheet Coordinators by contacting sponsors and the CRA for missing lab manuals and other needed material, including follow up with sponsors.
• Develop tracking system database for all issues and problems which develop during the protocol budget and drawsheet design process.