The ideal candidate will be an experienced clinical research professional and registered nurse who combines strong leadership capabilities with deep knowledge of clinical trials. This individual ensures high-quality research operations, promotes a culture of clinical excellence, and supports staff and investigators in delivering safe, ethical, and efficient studies.
KEY RESPONSIBILITIES
Work Assignments and Supervision of Staff Oversees the entire organization and implementation of all study activities and logistics (i.e., obtaining CTRC approval, creation of order sets, medication orders, etc.). Responsible for working one on one with all research staff to implement new studies which includes, training, mentoring and/or assigning mentoring, work schedule, providing training resources, tools, and meeting routinely to assess performance progress. Ensures that appropriate personnel are in place before new research projects and/or protocols are implemented. Coordinates, schedules, and attends all start-up meetings for new protocols. Prepares and plan/logistics of research study with assigned research personnel prior to start-up meeting. Manages and evaluates the clinical services delivered by research personnel for multiple research protocols. Directs departmental research staff in appropriate methods for managing protocol-related costs and charge recapture and provides quality assurance for the charge process. Coordinates and communicates all activities of the study plan and logistics with the PI, research nurse and the sponsor. Communicates with the supervisor, physician and/or protocol sponsor prior to implementation of a new protocol (i.e., planning, implementation, and evaluation).
Protocol Planning, Development and Management Responsible for the effective operation of department protocols in collaboration with the principal investigator, protocol administration team, financial analyst and study sponsor. Reviews proposed studies and provides feedback regarding potential patient/protocol management issues prior to study submission or activation including but not limited to study schedule, managing study drug toxicity, adverse event reporting and data capture for study endpoints.
In collaboration with protocol administration team, assesses departmental protocols for acuity and/or patient complexity to incorporate staffing and training needs. Reviews and provides input on study budget to ensure adequate staffing or protocol needs are negotiated; Reviews and provides input on contract to ensure protocol and contract compliance can be achieved. Directs and maintains timely accountability of study research staff in appropriate methods for managing protocol-related costs and charge capture; provides quality assurance for the charge process (e.g., review of study milestone logs or other applicable systems). Responsible for teams/self in assessing, coordinating, managing, and evaluating the care of patients on clinical trials. Ensures and/or provides advanced assessment of patients for protocol eligibility. Ensures study team collaboration with primary investigators and attending physicians regarding toxicity assessment and grading, treatment guidelines, and response assessments. Communicates and works cooperatively and effectively with clinic, nursing and departmental staff. In collaboration with supervisors and study teams, oversees all start-up aspects of protocols including Clinical Content Tools, CTRC requirements, and sampling pathways such as Z-Code applications. Participates in data analysis and quality assurance initiatives. Manages the clinical services delivered by research personnel for multiple research protocols. Assures excellence of clinical practice and patient care services through care delivery that is in accordance with federal, state and professional standards, policies and procedures. Interprets and upholds nursing, hospital, regulatory and departmental policies and procedures. Maintains and ensures knowledge of the research process and resources available in compliance with institutional policies, IRB and federal regulations. Provides consultation and information to nursing staff and physicians regarding the treatment of protocol patients on non-service units. Assists in the development of nursing care procedures related to patient care and protocol management. Collaborates with physicians and other disciplines to coordinate the delivery of care.
Financial Management Demonstrates understanding and assist the financial analyst with budget planning process and completion for all sponsored protocols.
Ensures each assigned research personnel have a patient payment tracking spreadsheets for all sponsored protocols to capture payment time points. Reviews the payment tracking spreadsheet with financial analyst monthly to ensure all payments are being captured at contractual timepoints/milestones. Reviews all coverage analysis to ensure appropriate charges are captures. Ensures appropriate charges and reimbursement for patient-related protocol costs. Reviews coverage analysis with PI and Research Nurse prior to obtaining signature. Reviews budget template with the financial analyst to ensure all financial information has been captured and is correct on the budget for all sponsored protocols. Meet quarterly with grant program manager to confirm effort for research personnel.
Other duties as assignedEDUCATIONRequired: Bachelor's Degree Nursing.
Preferred: Master's Degree Nursing.
WORK EXPERIENCERequired: 5 years Registered nursing experience to included two years of research nursing experience and two years of supervisory experience.
Preferred: Clinical research
Successful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience. Completion of both programs can be substituted for a maximum of two years of supervisory or management experience.
LICENSES AND CERTIFICATIONS- Required: RN - Registered Nurse - State Licensure State of Texas Professional Nursing License (RN). Upon Hire and
- Required: BLS - Basic Life Support Upon Hire or
- Required: Cardiopulmonary Resuscitation (CPR) Upon Hire
- Preferred: ACLS - Advanced Cardiac Life Support Certification as required by patient care area. Upon Hire
- Preferred: PALS - Pediatric Advanced Life Support Certification as required by patient care area. Upon Hire
OTHER REQUIREMENTS: Must pass pre-employment skills test as required and administered by Human Resources.
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.
