The Department of Investigational Cancer Therapeutics conducts broad Phase 1 studies across disease boundaries and molecular targets. We strive to provide outstanding patient care while performing innovative Phase 1 trials with new drugs that may eventually improve the management of cancer.
The primary purpose of the Senior Coordinator, Clinical Research Program position is to provide advanced administrative services for the coordination of phase I research studies, sponsored agreements and contracts. Exercises considerable discretion in the implementation, analysis, and reporting of research activities within the program.
The ideal Senior Coordinator, Clinical Research Program candidate will have prior clinical research experience with regulatory expertise in IRB submissions, FDA submissions, and regulatory documentation.
Minimum $32.21/hour - Midpoint $40.14/hour - Maximum $48.08/hour
Work Location: Texas Medical Center
The typical work schedule is Hybrid times a month and additional based on business needs.
Responsibilities
Research Protocol Development & Activation
• Collect and develop criteria information for protocol submission
• Participate in the preparation and drafting of protocols under the direction of the principal investigator
• Participate in budgeting activities related to clinical research
• Maintain a processing and tracking system for protocol-related documentation
• Submit FreD checklists and compliance documents for clinical trial agreement review, negotiation, and execution
• Interact with institutional staff to facilitate timely protocol approvals
• Keep principal investigators informed of protocol approval and clinical trial agreement issues
• Coordinate with the VP Office for Research Administration regarding investigator-held IND activities
• Attend planning meetings, including site initiation visits (SIVs)
• Provide protocol and informed consent training to clinical fellows and educate staff on regulatory submission processes
Protocol Administration & Maintenance
• Coordinate regulatory correspondence for active clinical research studies
• Communicate verbally and in writing with internal reviewers, pharmaceutical sponsors, and government agencies
• Complete required forms and ensure compliance with institutional, state, and federal requirements
• Prepare reports for surveillance committees and sponsoring agencies according to reporting requirements
• Collaborate with Patient Business Services to develop research charge tickets for protocols
• Coordinate protocol amendments with appropriate institutional stakeholders
• Support and coordinate Food and Drug Administration submissions
• Participate in research audits and regulatory reviews as required
Data Analysis & Reporting
• Review and evaluate clinical protocol data for completeness and accuracy
• Analyze protocol documents, abstracts, study text, and informed consent materials
• Provide data analysis and interpretation to support manuscripts, presentations, and grant research plans
• Assist with preparation of technical reports, abstracts, posters, presentations, spreadsheets, and manuscripts
• Draft reports, presentations, and manuscripts under principal investigator direction
• Copyedit technical reports and scientific documents
• Proofread publication materials and galley proofs prior to publication
• Interact with the National Cancer Institute and pharmaceutical sponsors to update protocol documentation
Department Statistics & Reporting
• Track protocol accrual data by month and fiscal year
• Monitor screen failure metrics and related study statistics
• Maintain patient and protocol data by tumor type and study category
• Track sponsored versus investigator-initiated studies and federal versus industry-supported protocols
• Collect and compile data for ad hoc departmental reporting requests
• Create and maintain graphical statistics presentations using PowerPoint
• Update departmental reporting metrics on a monthly basis
Training, Mentoring & Operational Support
• Train and mentor new coordinators in protocol development, activation, and maintenance processes
• Assist with employee counseling related to institutional policies and procedures
• Provide input for performance evaluations
• Deliver training and guidance on protocol-related policies and procedures
• Plan, design, and conduct educational programs for professional and ancillary staff
• Develop presentations and written communications to disseminate regulatory and operational information
• Conduct departmental training sessions to ensure compliance with internal and external requirements
• Perform additional duties as assigned
EDUCATION
• Required: Bachelor's degree
• Preferred: Master's degree
WORK EXPERIENCE
• Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. With preferred degree, three years of required experience
• Preferred: Prior clinical research experience with regulatory expertise in IRB submissions, FDA submissions, and regulatory documentation.
• May substitute required education degree with additional years of equivalent experience on a one to one basis
The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.
