MD Anderson Cancer Center Research Nurse - Pediatrics Research in Houston, Texas
Research Nurse Opportunity with Pediatrics Research
Ideal candidate must have a Bachelor's degree, TX RN license and two years of recent Clinical Nurse expereince.
The RN actively participates in the different clinical research functions which include: consenting and screening patients for protocol enrollment; registering patients onto various clinical trials (Children's Oncology Group, POETIC, pharmaceutical, and MDACC); coordinating protocol specimens; completing case report forms; electronic data entry in the different databases (departmental, institutional, and external). Other responsibilities include: protocol submission as needed; responding to queries and contingencies; preparing protocol-related reports (Serious Adverse Events, protocol deviations and violations, Continuing Review, IND Annual Report, Study Update); active participation in study monitoring and audits; developing research tools; and providing education to the other research staff and ancillary personnel.
JOB SPECIFIC COMPETENCIES
Protocol Management Participates in protocol planning prior to study initiation by developing checklists, sample research CSRs and other tools; Identifies, screens and verifies information for patients that are expected to be enrolled onto clinical trial protocols with MDACC, the Children's Oncology Group, consortium, or a pharmaceutical company; Participates in consent process and provides phlebotomy services to obtain samples from study participants; 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; Provides 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 drug and coordinate with clinical nurse to verify good documentation practices prior to 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 (i.e. due dates are within 6 weeks of the expected protocol reporting date for paper study and at the time of the expected protocol reporting date for electronic remote entry study). Enters data into case report forms using 100% source documentation 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 interval (interim), annual report, and/or final report writing, IND safety reports and other pertinent information throughout conduct of study. Develops protocol-specific treatment orders to be reviewed and finalized by the Principal Investigator. Submits final treatment orders to 'Clinical Effectiveness Department' to be uploaded into 'Clinic Station Order Sets'. Develops protocol-specific research tools (patient's calendar, diary, patient's discharge instructions etc.).
Database Administration and Audit Prep Is proficient in multiple database systems: MDACC's EPIC, CARE, PDMS, PDOL, various Pediatric databases (Patients, Protocol, CCG), and the web-based remote data entry system for the Children's Oncology Group (RDE and eRDE) and pharmaceutical study sponsors. Updates these various database systems by adding new records or entering data (i.e. demographic, disease, survival, protocol, administrative information) daily in order to maintain current data for the UTMDACC 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 team or departmental requests. Confers with physician in developing these plans and 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.
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 record. For cooperative group audits, supplies missing information or corrections prior to the audit, during the audit or 2 weeks after the audit.
Communications Daily ongoing oral or written communications involve study investigators, study collaborators, 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.
Other duties as assigned
Education: Graduation from an accredited school of professional nursing.
Preferred Education: Bachelor's Level Degree
Certification: Current State of Texas Professional Nursing license (RN).
Preferred Certification: Certification as a Clinical Research Professional.
Experience: Two years registered nurse experience.
Preferred Experience: None
Onsite Presence: Is Required
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
Employee Status: Regular
Minimum Salary: US Dollar (USD) 56,000
Midpoint Salary: US Dollar (USD) 78,500
Maximum Salary : US Dollar (USD) 110,000