MD Anderson Center
Research Nurse - Division of Clinical Research
MD Anderson Center, Houston, Texas, United States, 77246
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.
SUMMARY
The primary purpose of this position is to provide and coordinate independent, advanced research and protocol-related clinical aspects of investigational trials in collaboration with the multidisciplinary team and external sponsors to achieve quality clinical trials outcomes. Scope of position is defined by the Nurse Practice Act of the State of Texas and requires adherence to the policies and procedures of the institution.
KEY FUNCTIONS
Coordination of Care 40%
Manages resources available to facilitate informed consent process across a spectrum of treatment, interventional, and non-interventional trials.
Verifies eligibility and provides feedback to physicians and multidisciplinary team regarding required screening activities and scheduling time constraints. Schedules patient tests, keeps patients informed about test results and studies.
Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. Tracks protocol related labs, responses and research tests.
Monitors patients on chemotherapy, immunotherapy, and cell therapy treatment trials and communicates determination of dose delays and dose reductions based on hematological as well as clinical criteria to treatment team.
Identify and address the educational, emotional, and psychosocial needs of patient and their families while participating on a clinical trial.
Utilize the OneConnect system to make sure research charges are documented appropriately and that billing to sponsored study accounts is accurate.
Protocol Management 30%
Maintains expert knowledge of adverse events and policies regarding reporting. Prepares and reviews necessary data for monitoring visits, audits, and safety summaries.
Leads patient-update calls with sponsor.
Collects and develops critical information for protocol submission and revisions.
Coordinates FDA documentation including collecting, de-identifying, and submitting serious adverse event documentation to protocol sponsor and oversight groups such as the Investigational New Drug Office or Clinical Research Organization. If required for multi-center trials, maintain contact with other participating institutions and coordinate all data pertaining to such studies.
Demonstrates knowledge of research process, Code of Federal Regulations and ICH Guidelines for Good Clinical Practice (ICH-GCP). Demonstrates competence in key aspects of data collection and data entry incorporating institutional guidelines.
Demonstrates knowledge of the current NCI-Common Toxicity Criteria and institutional reporting requirements.
Patient care 30%
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 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.
EDUCATION
Required:
Graduation from an accredited school of professional nursing.
Preferred:
Bachelor's Level Degree.
EXPERIENCE
Required:
One year of registered nurse experience.
Preferred:
Prior Research Nurse and/or Oncology experience.
LICENSURE / CERTIFICATION
Required:
Current State of Texas Professional Nursing License (RN).
Basic Life Support (BLS) or Cardiopulmonary Resuscitation (CPR) certification.
SUMMARY
The primary purpose of this position is to provide and coordinate independent, advanced research and protocol-related clinical aspects of investigational trials in collaboration with the multidisciplinary team and external sponsors to achieve quality clinical trials outcomes. Scope of position is defined by the Nurse Practice Act of the State of Texas and requires adherence to the policies and procedures of the institution.
KEY FUNCTIONS
Coordination of Care 40%
Manages resources available to facilitate informed consent process across a spectrum of treatment, interventional, and non-interventional trials.
Verifies eligibility and provides feedback to physicians and multidisciplinary team regarding required screening activities and scheduling time constraints. Schedules patient tests, keeps patients informed about test results and studies.
Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. Tracks protocol related labs, responses and research tests.
Monitors patients on chemotherapy, immunotherapy, and cell therapy treatment trials and communicates determination of dose delays and dose reductions based on hematological as well as clinical criteria to treatment team.
Identify and address the educational, emotional, and psychosocial needs of patient and their families while participating on a clinical trial.
Utilize the OneConnect system to make sure research charges are documented appropriately and that billing to sponsored study accounts is accurate.
Protocol Management 30%
Maintains expert knowledge of adverse events and policies regarding reporting. Prepares and reviews necessary data for monitoring visits, audits, and safety summaries.
Leads patient-update calls with sponsor.
Collects and develops critical information for protocol submission and revisions.
Coordinates FDA documentation including collecting, de-identifying, and submitting serious adverse event documentation to protocol sponsor and oversight groups such as the Investigational New Drug Office or Clinical Research Organization. If required for multi-center trials, maintain contact with other participating institutions and coordinate all data pertaining to such studies.
Demonstrates knowledge of research process, Code of Federal Regulations and ICH Guidelines for Good Clinical Practice (ICH-GCP). Demonstrates competence in key aspects of data collection and data entry incorporating institutional guidelines.
Demonstrates knowledge of the current NCI-Common Toxicity Criteria and institutional reporting requirements.
Patient care 30%
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 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.
EDUCATION
Required:
Graduation from an accredited school of professional nursing.
Preferred:
Bachelor's Level Degree.
EXPERIENCE
Required:
One year of registered nurse experience.
Preferred:
Prior Research Nurse and/or Oncology experience.
LICENSURE / CERTIFICATION
Required:
Current State of Texas Professional Nursing License (RN).
Basic Life Support (BLS) or Cardiopulmonary Resuscitation (CPR) certification.