Research Nurse - Pediatrics

The University of Texas MD Anderson Cancer Center is ranked the nation's top hospital for cancer care by U.S. News & World Report's "Best Hospitals." MD Anderson's mission is to eliminate cancer in Texas, the nation and the world through exceptional programs that integrate patient care, research and prevention.

Oncology nursing excellence is a central pillar in MD Anderson's worldwide reputation for cancer care. MD Anderson nurses are bright, motivated and caring. Nearly 3,000 professional nurses work in our clinics and hospital as direct care providers, research nurses, advanced practice registered nurses, case managers and in numerous other roles. As a Magnet Recognized hospital, we provide our patients with excellent oncology nursing care

JOB-SPECIFIC COMPETENCIES

Shift/Hours: Monday - Friday / 8am - 5pm

Clinical Trials Management:

· Participates in protocol planning before study initiation by developing checklists.

· Identifies, screens, and verifies information for patients that are expected to be enrolled in clinical trial protocols with MDACC, the Children's Oncology Group, a consortium, or a pharmaceutical company.

· Responsible for coordinating with clinical nurses and physicians to ensure all baseline tests are ordered and completed, including participating in the informed consent process and enrolling patients that meet the protocol eligibility criteria.

· Provide direction and training to nursing staff on techniques for mixing and administering new drugs and other forms of patient care and treatment unique to the study being conducted.

· Maintain interface with nursing and other professional personnel to interpret protocol application for a given patient and to answer questions about the study in progress.

· Responsible for ensuring all tests and procedures during the conduct of the study are met (by coordinating, ordering/scheduling, and verifying) according to the protocol and guidelines for Good Clinical Practice and sends reminders as needed.

· May administer investigational drugs and coordinate with a clinical nurse to verify good documentation practices pre and post-dose monitoring.

· Gathers, abstracts, verifies, and reports patients' data (treatment, toxicity, and other critical events).

· The general data quality must be accurate, complete, legible, and timely.

· Enters data into case report forms using 100% source document verification.

· Performs quality checks on source documents specific to the study.

· Utilizes knowledge of disease processes to observe and report adverse events and protocol violations/deviations in a timely and accurate manner to ensure the health, safety, and welfare of the participant.

· Acts as a liaison for principal investigators and study sponsors to ensure protocol compliance (contacts sponsor to resolve study questions or notification of Severe Adverse Events).

· Participates in the interval (interim), annual report, and/or final report writing, IND safety reports, and other pertinent information throughout the conduct of the study.

· Develops protocol-specific treatment orders to be reviewed and finalized by the Principal Investigator.

· Submits final treatment orders. Develops protocol-specific research tools (patient's calendar, diary, patient's discharge instructions, etc.).

Database Administration and Audit Preparation:

· Proficient in multiple database systems: various Pediatric databases and the web-based remote data entry system for the Children's Oncology Group and pharmaceutical study sponsors.

· Updates various database systems by adding new records or entering data (i.e. demographic, disease, survival, protocol, administrative information) daily to maintain current data for the Children's Cancer Hospital, the Children's Oncology Group, or pharmaceutical sponsors.

· Retrieves data from the databases by generating standard queries and/or reports and uses them to prepare tables for presentations, grants, or other planning strategies/events as needed for disease-specific teams or departmental requests.

· Consults with physicians in developing protocols for clinical research studies and discusses the interpretation of results and the preparation of manuscripts for publication.

· Reviews journals, abstracts, and scientific literature to keep abreast of new developments and obtains information regarding previous studies to aid in the planning of new studies.

· Manages protocol compliance involving quality assurance and compliance with applicable regulatory requirements.

· Collects and reports protocol-specific information.

· Supports internal and external audits by providing data and documentation.

· Flags patient's medical record for laboratory items, drug dosages, toxicity, tumor response, adverse events, or other critical event time points for audits conducted by the cooperative group, company sponsor, or FDA.

· Is present or available at the time the audit is conducted to assist the auditors with questions and handling the medical records. For cooperative group audits, supply missing information or corrections before the audit, during the audit, and after the audit.

Communication:

· Daily ongoing oral or written communications involve study investigators, study collaborators, and clinical and ancillary staff within the division, institution, and outside the institution to ensure required protocol requirements are met for eligibility, treatment compliance, required observations/evaluation time points, tumor measurements, pathology/radiotherapy materials or follow-up for adherence and compliance with SOPs, FDA regulations, GCP, and ICH guidelines.

· Attend investigator's meetings, pre-study site visits, study initiation visits, and all other study-related visits by monitors or sponsor representatives.

· Attend cooperative group meetings or educational conferences periodically.

· Attend weekly Pediatric Tumor Board and Grand Rounds, morning reports, and team meetings.

Education and Training :

· Helps train Research Nurses, Coordinators, and other research personnel by serving as a mentor.

· Precepts and assists in the training and mentoring of new research staff.

· Communicates policy and procedures to personnel in the research area in accordance with institutional and departmental policies and procedures.

· Assists in the development and enforcement of SOPs and other practices which enhance workflow and performance.

· Oversees the cross-coverage schedule.

Patient care:

· Evaluates response to treatment, grading toxicities and adverse treatment reactions through personal interviews, by visually monitoring the medical record and or by talking with patient and or family members and local physicians.

· Provides quality patient care in relation to the patient's prescribed diagnosis, treatment, age group, development, and other identified needs.

· Identifies and provides patient and family educational needs regarding treatment management, evaluation, and follow-up on clinical trials and research protocols through talking with patients and families person to person and by telephone and synthesizing information provided.

Other duties as assigned.

Requires flexibility in work schedule as needed for patients and business needs. Occasionally, may attend meetings/work responsibilities outside of the set schedule.

REQUIREMENTS

Education Required: Graduation from an accredited school of professional nursing.

Education Preferred: Bachelor's of Science in Nursing.

Experience Required: One year of experience in an acute care setting

Experience Preferred: Two years relevant clinical nursing experience.

Licensure/Certification Required: Current State of Texas Professional Nursing license (RN). Basic Life Support (BLS) or Cardiopulmonary Resuscitation (CPR) certification.

Licensure/Certification Preferred: Certification in oncology or specialty practice area. American Heart Association Basic Life Support (BLS), ACLS (Advanced Cardiac Life Support) or PALS (Pediatric Advanced Life Support) certification as required by patient care area.

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. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

Additional Information

Requisition ID: 171353

Employment Status: Full-Time

Employee Status: Regular

Work Week: Evening/Night

Minimum Salary: US Dollar (USD) 70,500

Midpoint Salary: US Dollar (USD) 91,500

Maximum Salary : US Dollar (USD) 116,500

FLSA: exempt and not eligible for overtime pay

Fund Type: Hard

Work Location: Onsite

Pivotal Position: No

Referral Bonus Available?: No

Relocation Assistance Available?: No

Science Jobs: No

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