Senior Coordinator, Clinical Research Program

Work Location: Texas Medical Center

About the Role

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. This position provides advanced administrative services for the coordination of phase I research studies, sponsored agreements, and contracts. The role exercises considerable discretion in the implementation, analysis, and reporting of research activities within the program.

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

Requirements

• 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

Pay

Minimum $32.21/hour - Midpoint $40.14/hour - Maximum $48.08/hour

Schedule

The typical work schedule is hybrid, with onsite work required multiple times a month and additional onsite days based on business needs.

Benefits

• Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance
• Accruals for Paid Time Off (PTO) and Extended Illness Bank, plus paid holidays
• Wellness, childcare, and other leave options
• Tuition Assistance Program after six months of service
• Access to extensive wellness, fitness, and employee resource groups
• Defined-benefit pension through the Teachers Retirement System
• Voluntary retirement plans
• Employer-paid life and reduced salary protection programs