Stanford University, Cancer Clinical Trials Office (CCTO) in the Pediatric Hematology Oncology Clinical Research Group is seeking a Research Nurse 1 to work under the direct supervision of the principal investigator and/or senior research nurse/research nurse manager in pediatric hematology, apply medical knowledge and experience to coordinate and implement the clinical course of pediatric research participants in complex hematology clinical trials. Assess physical health and administer treatments throughout the study aligned with "Scope of Practice" delegated responsibilities. Support study conduct and ensure pediatric study participant safety.
- Support the safety of study participants and maintain communication with their families/caregivers and clinicians.
- Provide clinical and administrative nursing support for research clinical trials based on scope of practice. Collaborate with clinical staff, researchers, outside vendors, and other staff to administer treatment and study protocols. May coordinate multi-site studies.
- Conduct study participant evaluations according to the study protocol, assess adverse events, and apply triage and judgment to determine course of action.
- Administer medications and treatments per study protocol for out study participant research participants. May collect, process, and ship lab specimens.
- Comply with institutional policies, standard operating procedures, and guidelines, and prepare and submit documentation as required by the study protocol, study sponsor, and regulatory authorities. Manage essential regulatory documents and handle confidential information (verbal and written) with tact and diplomacy, adhering to all HIPAA guidelines.
- Supervise research staff, coordinating staffing or scheduling assignments as needed.
- Participate in budget preparation and billing reconciliation.
- Identify, recruit, and enroll study participants. Participate in the informed consent process.
- Participate and host monitor visits.
- Assist sponsor investigator research with Investigational New Drug/Investigational Device Exemption applications.
* - Other duties may also be assigned.
Experience working in pediatric hematology clinical research studies or experience in pediatric hematology. Society of Clinical Research Associates or Association of Clinical Research Professionals certification.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in nursing or equivalent, and two years of experience in nursing, preferably in a research setting.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Demonstrated ability to work with research subjects of all ages and backgrounds.
- Verbal and written communication skills to convey medical and research-related information to research subjects of all ages and backgrounds.
- Ability to identify confidential and sensitive information (written and verbal).
- Ability to implement good clinical practices in all interactions with study participants, their families, and colleagues.
- Ability to identify adverse reactions to study treatments and the required study protocol documentation to record these activities.
- Ability to implement study protocols with supervision.
- Ability to provide work direction to research support staff.
- Demonstrated understanding of good clinical practices and regulatory compliance.
- Demonstrated experience with electronic data capture, including database management.
- Demonstrated ability to perform the functions of the position with some supervision.
CERTIFICATIONS & LICENSES:
- Current license as a California Registered Nurse.
- Current basic CPR certification.
- Frequently stand/walk, sit, perform desk-based computer tasks, use a telephone, writing by hand, sort/file paperwork or parts, twist/bend/stoop/squat, and grasp lightly/fine manipulation.
- Occasionally reach/work above shoulders, grasp forcefully, operate foot and/or hand controls.
- Rarely kneel/crawl, climb (ladders, scaffolds, or other), scrub/sweep/mop/chop/mix, operate a manual pipette.
- Ability to obtain and maintain a valid California non-commercial class license and operate vehicle during daylight hours
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
- May be required to work with, take specific precautions against, and/or be immunized against potentially hazardous agents.
- May be exposed to blood borne pathogens.
- Some travel might include international travel.
WORK STANDARDS (from JDL):
- When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.