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Job description
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.
Why Us?
At UT MD Anderson, this role directly supports groundbreaking Phase I clinical research that advances cancer treatment and patient care. Team members participate in innovative studies, collaborate with leading investigators and sponsors, contribute to scientific publications and regulatory activities, and benefit from opportunities for professional growth, training, mentoring, and work-life balance through a hybrid work environment.
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 PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.
Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.
Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.
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.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law.
Additional Information
Requisition ID:
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 67,000
Midpoint Salary: US Dollar (USD) 83,500
Maximum Salary : US Dollar (USD) 100,000
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Hybrid Onsite/Remote
Pivotal Position: No
Referral Bonus Available?: No
Relocation Assistance Available?: No
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Worksite address
houston, TX, 77246, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.