RN Clinical Research Coordinator
Stanford University is seeking a Research Nurse 2 who will be under the direction of the principal investigator and research nurse manager, applying medical knowledge and experience to oversee and direct clinical course of research participants in clinical trials in the Stanford Center for Inherited Cardiovascular Diseases. This is an opportunity to work with an engaged, motivated patient population in clinical trials of new investigational agents. Assess physical health and administer treatments throughout the study aligned with "Scope of Practice" delegated responsibilities. Oversee study conduct and ensure study participant safety.
- Ensure the safety of study participants, and maintain communication with their families/caregivers and clinicians.
- Provide clinical and administrative nursing support and oversight 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.
- Develop and manage budget for research study, and oversee resources including funds, personnel, and equipment as needed. Coordinate and collaborate with principal investigator to review study protocol and assess and analyze feasibility, budget projections, and staffing needs.
- Conduct study participant evaluations according to the study protocol, assess adverse events, and apply triage and judgment to determine course of action.
- Oversee and potentially administer medications and treatments per study protocol for out study participant research participants.
- 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. Interpret complex protocols and regulatory requirements. Oversee and manage essential regulatory documents and handle confidential information (verbal and written) with tact and diplomacy, adhering to all HIPAA guidelines.
- Supervise non-clinical research staff as needed.
- Identify, recruit, and enroll study participants, as well as maintain study participant records and determine study participant criteria.
- Host external audits (Food and Drug Administration, National Institutes of Health, etc.).
* - Other duties may also be assigned
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor's degree in nursing or equivalent, and five years of experience in nursing, with at least two years 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 minimal supervision.
- Ability to provide work direction to research support staff.
- Demonstrate 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 minimal supervision.
CERTIFICATIONS & LICENSES:
- Current license as a California Registered Nurse.
- Certified Research Administrator or Clinical Research Coordinator preferred.
- 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.
- On call 24 hours/day.
- Frequent travel, might include international travel.
- 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.