Senior Research Nurse - Investigational Cancer Therapeutics

The Department of Investigational Cancer Therapeutics conducts broad phase I studies across disease boundaries and molecular targets.  We strive to provide outstanding patient care while performing innovative phase I trials with new drugs that may eventually improve the management of cancer.  

The ideal candidate will have prior experience, as Research Nurse, with clinical trials in Radiation Therapy, Neurology or Oncology. Phase 1 clinical trial prior experience at MD Anderson preferred. 

KEY FUNCTIONS

Coordination and oversight of activities related to initiation and conduct of clinical trials.

Work with staff in Patient Business Services / complete research charge tickets for protocols.

Interact with clinic staff to make sure research charge tickets are used appropriately and that billing to sponsored study accounts is accurate.

Timely notification of patient on study to patient access coordinator and CORE.

Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.

Coordinate, evaluate, and follow the patient’s participation in clinical settings.  Provide collaborative oversight for the multidisciplinary team as necessary to document patient care, achieve objectives of phase I trials, and maintain patient safety.

Instruct co-workers in allied fields in procedures for recording patient information.

Participate in maintaining data necessary for audits, supervise audits, and oversee coordination of FDA audits.

Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.

Provide leadership for the overall effective operation of designated protocols, which includes development, design, and resolution of operations and budget issues in collaboration with the principal investigator or study sponsor.

Cost Analysis

Provide leadership for a multidisciplinary team to effectively meet protocol goals.

Coordination of regulatory correspondence on clinical research studies.

Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).

Complete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.

Direct support to clinical trial research protocols.

Review protocol documents including abstracts, text and informed consent for relevant information.

Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in CORE per protocol.  Communicate necessary registration information to sponsoring drug company as directed by PI, and with the assistance of the research nurse.

Schedule patient tests; keep patients informed about test results and studies.

Assist in obtaining consent for studies.

Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies.  If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data pertaining to such studies.

Complete case report forms in a timely and accurate fashion.

Assist in the assessing for adverse events.

Assist in modifying consents; submit to IRB.

Follow patients while on study for safety monitoring. Adhere to institutional policies concerning safety and infection control.

Provide support for labor-intensive protocols as needed.

Monitor protocol compliance by assisting in coordination of protocol-specific lab, radiographic, and clinical evaluation of patients.

Act as a lead in data collection by retrieving protocol information via computer and visual chart review and by communicating directly with outlying healthcare providers to schedule and procure testing and treatment records.

Obtain outside films, surgical, pathology and lab reports as needed per protocol and submitting specimens/films for reading.

Process samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures.

Develop and maintain database for tracking specimens with high level of accuracy.

Serve as an information source regarding status of samples collected from patients on given protocols for PI and sponsors.

Oversee, coordinate, and participate in the collection and evaluation of data for principal investigators.

Monitor the retrieval of protocol-related data as documented in the medical record and ensure accurate entry into a computerized database or on a handwritten case report form.

Generate PDMS data reports, protocol summary reports, and user-generated data reports as requested.

Compile protocol and other data for manuscript submissions.

Provide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.

Training and mentoring

Train and mentor new study coordinators and data coordinators to perform the functions delineated in their position descriptions.

Assist with supervisory functions such as counseling employee regarding institutional policies and procedures.

Provide input for performance evaluations.

Provide training and guidance regarding the policies and procedures that are related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.  Monitor accuracy compliance by study coordinators and data coordinators by performing QA audits.

Plan, design, and conduct complex professional and ancillary staff education and disseminate information by means of training sessions/presentations and/or written communications.

Conduct department training sessions to ensure protocol compliance and dissemination of new information and policies.

To maintain a high level of professional expertise and credibility through educational programs, including on-site training and off-site conferences.

Attend department research meetings and conferences.

Attend approved off-site meetings and conferences.

Supplement education as needed through use of reference materials, lectures, etc.

Other duties as assigned.

MD Anderson offers our employees:

* Paid employee medical benefits (zero premium) starting on first day for employees who work 30 or more hours per week.

* Group Dental, Vision, Life, AD&D and Disability coverage.

* Paid time off (PTO) and Extended Illness Bank (EIB) paid leave accruals.

* Paid institutional holidays, wellness leave, childcare leave, and other paid leave programs.

* Tuition Assistance Program after six months of service.

* Teachers Retirement System defined-benefit pension plan and two voluntary retirement plans.

* Employer paid life, AD&D and an illness-related reduced salary pay program.

* Extensive wellness, recognition, fitness, employee health programs and employee resource groups.

* Opportunities for professional growth through Career Development Center and Mentoring programs.