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Clinical Research Nurse Specialist
2 months ago
Position Overview:
Stanford University, within the Department of Pediatrics, is in search of a part-time (50%) Clinical Research Nurse Specialist to leverage medical expertise and experience in overseeing the clinical management of research participants involved in clinical trials.
Key Responsibilities:
Assess the physical well-being of participants and administer treatments throughout the study in accordance with the defined scope of practice and delegated duties. Ensure the integrity of study conduct and prioritize participant safety.
Manage and coordinate care for individuals enrolled in clinical research trials, which includes the preparation and submission of protocol-related documents and amendments to regulatory bodies, participant identification and recruitment, informed consent acquisition, financial management related to the protocol, and ensuring compliance with billing practices. Responsibilities also encompass performing phlebotomies, IV insertions, skin prick tests, and maintaining source documentation for phases 1-3 of studies.
Additional Duties:
Engage in study design, maintain communication with families, referring physicians, and other healthcare professionals, and provide education and guidance to participants and their families to ensure adherence and retention in the study. Track and document adverse events, conduct physical examinations to verify enrollment criteria, and monitor for any changes during participation. Formulate and assess treatment plans, be available for on-call consultations and emergencies between clinic visits, administer rescue medications based on clinical judgment, and assist in the analysis of study data.
- Ensure participant safety and maintain open communication with their families and healthcare providers.
- Provide both clinical and administrative support for research clinical trials, including obtaining comprehensive participant histories, conducting physical assessments, reviewing medical records, and prescribing medications as per established protocols.
- Collaborate with clinical staff, researchers, and external vendors to implement treatment and study protocols effectively.
- Evaluate, document, and manage adverse events, applying clinical judgment to determine appropriate actions.
- Administer medications and treatments in accordance with study protocols and professional scope of practice.
- Adhere to institutional policies, standard operating procedures, and guidelines; prepare and submit necessary documentation as required by the study protocol and sponsors; interpret complex protocols and regulatory requirements.
- Work closely with the principal investigator to review study protocols, assess feasibility, budget considerations, and staffing requirements.
- Supervise and mentor clinical and non-clinical staff/students as necessary.
- Identify, recruit, and enroll study participants while maintaining accurate participant records and determining eligibility criteria.
- Support research initiatives with investigational new drug/device exemption applications.
- Perform other related duties as assigned.
Compensation:
Stanford University provides a pay range that reflects its good faith estimate of what it expects to offer for this position. The compensation for the selected candidate will be influenced by factors such as the responsibilities of the role, the qualifications of the candidate, departmental budget constraints, internal equity, geographic location, and market pay for similar positions.
Desired Qualifications:
Familiarity with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and FDA regulations (CFR Title 21 part 312). Experience in overseeing outpatient clinical research studies is preferred. A valid Nurse Practitioner license is required.
Education & Experience:
A Bachelor’s degree, Nurse Practitioner license, and a minimum of three years of relevant experience, or a combination of education and experience.
Knowledge, Skills, and Abilities:
Ability to provide direction to research support staff, demonstrate understanding of good clinical practices and regulatory compliance, and perform job functions with minimal supervision. Strong verbal and written communication skills to convey medical and research-related information effectively. Ability to identify and handle confidential and sensitive information appropriately.
Licenses:
Must be licensed as a Registered Nurse by the California State Board of Registered Nursing and certified as a Nurse Practitioner. Current basic CPR certification is also required.
Physical Requirements:
Frequent standing, walking, sitting, and performing desk-based tasks. Occasional reaching above shoulders and grasping. Ability to maintain a valid California non-commercial class license and operate a vehicle during daylight hours.
Working Conditions:
May require working with potentially hazardous agents and exposure to bloodborne pathogens. On-call availability may be necessary.
Stanford University is committed to fostering a culture of diversity, equity, inclusion, and justice in all aspects of its work.
