Job Abstract

Research Nurse Manager - Gynecologic Oncology and Reproductive Medicine

Administration and Management
Partners with faculty and department leadership to assist in the development and administration of a strategic plan to manage departmental protocol activity. Develops and manages implementation systems, policies, and procedures affecting the clinical research operations, clinical trial coordination and management of study teams. Collaborates with faculty and department leadership in developing and reporting accrual metrics, ensuring accurate monitoring of data. Ensures timely updates by research staff in the CTMS system to maintain data accuracy for reporting and to ensure completion of downstream financial processes. Develops and maintains effective staffing model to ensure execution of department research goals. Ensures appropriate personnel are trained and in place before new research projects and/or protocols are implemented. Manages and coordinates clinical research activities across TMC, HALs, and LBJ. Develops strategies to promote enrollment of diverse patient populations.

Protocol Planning, Development and Management
Responsible for the effective operation of department protocols in collaboration with the principal investigator, protocol administration team, 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. Responsible for oversight of the collection and recording of research data. Participates in data analysis and quality assurance initiatives. 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.

Education/Training, Development & Mentoring
Builds capacity across the Gyn Onc research enterprise. Devises training and mentoring programs commensurate with the previous experience and proficiency level of research personnel. Schedules, coordinates, or conducts in-service training sessions for professional staff as needed. Coordinates training and collaborative efforts between TMC, HAL, and LBJ Research teams, to standardize procedures and enhance best practices across teams. Serves as a resource to nursing staff and others involved in the care of protocol patients regarding the risks and potential side effects of investigational drugs or drug combinations. Chairs or participates as an active member in nursing, hospital, and/or departmental committees or groups. Plans and participates in team and multidisciplinary conferences, specialized training, and in-service education programs to increase personal competence. Assists in evaluating own practice toward improvement of service to patients and families. Completes required continuing educational requirements for licensure and maintains current RN license in the state of Texas.

Other duties as assigned