Clinic Research Nurse

Children's Wisconsin•Milwaukee, WI

35d•Onsite

About The Position

Supports and initiates a wide variety of clinical research activities including informed consent, monitoring compliance with research protocols and regulatory requirements, coordination of therapy- and research-related care, and the collection, recording, reporting, and dissemination of research and program information. Areas of focus include maintaining knowledge of oncology and BMT research protocols, patient/family education, compliance with internal and external requirements for human subject research, and education of physicians, advanced practice providers, nurses, and clinical research staff. Data management responsibilities are accomplished in partnership with research coordinator staff and include patient tracking and reporting as required by individual protocols. Functions with demonstrated expertise and advanced knowledge in the delivery of direct and indirect nursing care to children, adolescents, and young adults involved in pediatric oncology and blood and marrow transplant clinical trials.

Requirements

Bachelor's Degree in Nursing
current Wisconsin RN license
2+ years experience as a registered nurse
Oncology or BMT experience
pediatric experience
BLS-Basic Life Support Healthcare Provider - American Heart Association/American Red Cross/National Safety Council required
License RN-Registered Nurse (30) - State of Wisconsin required

Nice To Haves

Experience in clinical research, including regulatory compliance and reporting
or relevant education
LPN-Licensed Practical Nurse (31) - State of Wisconsin within 1 Year preferred
Certified Pediatric Hematology Oncology Nurse - Oncology Nursing Certification Corporation preferred

Responsibilities

Applies advanced knowledge of oncology-blood and marrow transplant nursing care to coordinate treatment and specimen collection consistent with individual patients’ treatment plans and research protocols.
Makes decisions and establishes schedules based on time-critical sequences of events involving multiple departments.
Complies with Children’s Hospital of Wisconsin (CHW) and Medical College of Wisconsin (MCW) research-related policies and procedures as well as research-related requirements from regulatory agencies and research sponsors designed to protect human subjects enrolled in research studies, including subject recruitment, consent/assent, administration of study medications, use of study devices, surveys/tests/questionnaires, recording and obtaining data, and access to identified human data.
Monitors changes in research protocols that affect care, specimen collection, and reporting requirements.
Develops materials to inform physicians, advanced practice providers, nurses, and clinical research coordinators.
Develops and updates diagnosis and research-related teaching materials for patient families.
Uses nursing knowledge and skills to educate patients and families at the time of diagnosis and throughout therapy.
Develops and delivers nursing education focused on delivery of drug, side effects, precautions, timing of sample collections, and special collection requirements inconsistent with standard policies and procedures, e.g. atypical line flush etc.
Participates in informed consent conferences with patient families considering research-related therapy.
Independently obtains and documents informed consent for non-therapy-related research, e.g. biology and registry trials.
Facilitates communication between CHW and MCW institutional investigators, sponsors, and study coordinators, assuring flow of required data.
Works with principle investigators and research staff to collect and maintain patient data.
Establishes, maintains, and distributes research-related patient care records according to research treatment algorithms for all studies assigned.
In partnership with the treatment team and research coordinators, tracks patient progress through treatment making all research treatment procedures transparent to care providers, research staff, and families.
With the physicians and advanced practice providers, reviews treatment plans and toxicities with patient families.
Ensures patient/family understanding of possible side effects and what necessitates immediate reporting to clinical team.
Maintains knowledge of internal and external regulatory requirements for reporting adverse events.
Monitors compliance with research-related testing and procedures, as required by each trial.
Initiates and maintains cooperative relationships with other departments, assuring timely and complete information flow from surgery, radiology, pathology, laboratory, medical records, and other disciplines as well as other Oncology and BMT team members.
Identifies protocol requirements (and CHW order sets, as applicable) for the submission of specimens and radiographic data.
Serves as a resource to faculty, advanced practice providers, nursing staff, and clinical resource coordinators.
Provides formal and informal education to nursing and clinical research staff.
Works with principle investigators and research staff to develop, implement, and maintain information related to the research program.
Contributes to internal and external reporting about pediatric oncology-BMT research.
Identifies problems or obstacles in the system/procedures related to implementation of the clinical trials and communicates to the study investigators and research coordinators as appropriate.
Complies with HIPAA laws as well as Internal Review Board (IRB) and regulatory agency requirements.
Attends division, IRB, clinical research, and team meetings and teleconferences as appropriate.
Coordinates with CHW finance to obtain insurance authorization for clinical trials.
Communicates coverage plan for experimental care with patient families and providers.
In conjunction with the Clinical Research Coordinator, screens incoming patient and family inquiries for clinical trials.