Nurse Practitioner Clinical Research
University of California - San Francisco, Oakland, CA, United States
Job Overview
Under general supervision of several Department of Pediatrics investigators in the Division of Medical Genetics, the clinical research Nurse Practitioner will provide services supporting clinical research investigators and caring for research patients and research infusion patients. The role requires an understanding of research protocols and compliance practices, and the ability to assess patient needs, implement research protocols and nursing interventions, deliver treatment, monitor patients, and provide patient education.
Responsibilities
"Direct patient care includes initiating enzyme replacement therapy and other investigational treatments, administering medications and procedures, patient education, phlebotomy, vitals monitoring, and observation."
Research Specific Tasks
Utilize the nursing process in providing care for research patients in accordance with appropriate policies, procedures, and study protocols.
Assess, plan, implement, and evaluate the appropriate plan prior to initiating treatment.
Initiate intravenous (IV) via central port or peripheral access, intrathecal (IT), and intracerebroventricular (ICV) treatments and administer medication in a timely fashion; report and follow-up with investigators for any unusual occurrence that is treatment or study procedure related.
Act as the primary point of contact for on‑site and off‑site research, infusion‑related clinical questions (responsible for research clinic pager and responding to home nursing questions).
Complete monthly nursing assessment notes and participate in primary nursing patient care conference.
Comply with activities mandated by Hospital Policy and relevant research authorities.
Maintain knowledge of and adherence to established research, clinical and administrative policies and procedures.
Research Administrative Tasks
Ongoing protocol training and review.
Attend investigator meetings and research conferences.
Work with CRCs and UCSF/BCH staff to ensure study procedures are completed according to protocol, specimens are properly collected and stored, and required data is collected in a timely manner.
Participate in research improvement activities.
Support the management of infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation.
Support the management of activities for cohorts in various areas of studies and disciplines, including clinical trials in several disciplines.
Possibly participate in relevant subject matter conferences and contribute to study planning and updates with industry sponsors.
Support the Clinical Research Nurse Manager in managing tasks and time of research nurses depending on program needs.
Support the training of research nurses and CRCs on clinical protocol requirements.
Required Qualifications
Seven (7) years of Nurse Practitioner experience.
One to two (1–2) years of experience as a research RN or NP.
Doctorate degree (PhD or DNP).
Experience performing venipuncture to collect blood samples in a research setting.
Experience performing venipuncture in a pediatric population.
Experience accessing mediports.
Experience collecting blood samples from a central line.
Experience with central line maintenance, including dressing changes.
At least one peer‑reviewed publication (any authorship order).
Preferred Qualifications
In‑depth academic knowledge and applied background in clinical research philosophy, with the ability to adapt methods to particular situations and translate research objectives into an operational plan.
In‑depth knowledge of clinical research and drug development concepts, federal, state, and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials.
Additional preferred certifications: Good Clinical Practice (GCP), Collaborative Institutional Training Initiative (CITI), Human Subjects Protection (HSP).
Ability to access intracerebroventricular (ICV) ports and administer investigational products via ICV infusion.
Ability to complete lumbar punctures (LP) and administer intrathecal (IT) investigational products.
Demonstrable record of successfully running complex clinical research trials and designing and implementing quality control, protocol, and quality assurance systems according to accepted clinical standards.
License and Certification
California Registered Nurse (RN) License without restriction.
California Certified Nurse Practitioner (NP) without restriction.
California Nurse Practitioner Furnishing Number including Schedule II furnishing privileges.
NP national board certification from an accepted certifying agency aligned with the patient population and clinical role (Pediatric Outpatient).
California Driver License (if required for position).
Drug Enforcement Administration (DEA) Registration with Schedules 2, 2N, 3, 3N, 4, and 5 registered to a California address.
American Heart Association (AHA) Basic Life Support (BLS) certification.
Additional required AHA certifications: None besides BLS.
Additional required certifications (such as ENLS): None.
Equity Statement
The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.
Salary and Benefits
The final salary and offer components are subject to additional approvals based on UC policy. Placement within the salary range depends on work experience and internal equity for this position classification at UCSF. For positions represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. The benefits program, including total compensation, is available on the UCSF Compensation and Benefits portal.
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Under general supervision of several Department of Pediatrics investigators in the Division of Medical Genetics, the clinical research Nurse Practitioner will provide services supporting clinical research investigators and caring for research patients and research infusion patients. The role requires an understanding of research protocols and compliance practices, and the ability to assess patient needs, implement research protocols and nursing interventions, deliver treatment, monitor patients, and provide patient education.
Responsibilities
"Direct patient care includes initiating enzyme replacement therapy and other investigational treatments, administering medications and procedures, patient education, phlebotomy, vitals monitoring, and observation."
Research Specific Tasks
Utilize the nursing process in providing care for research patients in accordance with appropriate policies, procedures, and study protocols.
Assess, plan, implement, and evaluate the appropriate plan prior to initiating treatment.
Initiate intravenous (IV) via central port or peripheral access, intrathecal (IT), and intracerebroventricular (ICV) treatments and administer medication in a timely fashion; report and follow-up with investigators for any unusual occurrence that is treatment or study procedure related.
Act as the primary point of contact for on‑site and off‑site research, infusion‑related clinical questions (responsible for research clinic pager and responding to home nursing questions).
Complete monthly nursing assessment notes and participate in primary nursing patient care conference.
Comply with activities mandated by Hospital Policy and relevant research authorities.
Maintain knowledge of and adherence to established research, clinical and administrative policies and procedures.
Research Administrative Tasks
Ongoing protocol training and review.
Attend investigator meetings and research conferences.
Work with CRCs and UCSF/BCH staff to ensure study procedures are completed according to protocol, specimens are properly collected and stored, and required data is collected in a timely manner.
Participate in research improvement activities.
Support the management of infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation.
Support the management of activities for cohorts in various areas of studies and disciplines, including clinical trials in several disciplines.
Possibly participate in relevant subject matter conferences and contribute to study planning and updates with industry sponsors.
Support the Clinical Research Nurse Manager in managing tasks and time of research nurses depending on program needs.
Support the training of research nurses and CRCs on clinical protocol requirements.
Required Qualifications
Seven (7) years of Nurse Practitioner experience.
One to two (1–2) years of experience as a research RN or NP.
Doctorate degree (PhD or DNP).
Experience performing venipuncture to collect blood samples in a research setting.
Experience performing venipuncture in a pediatric population.
Experience accessing mediports.
Experience collecting blood samples from a central line.
Experience with central line maintenance, including dressing changes.
At least one peer‑reviewed publication (any authorship order).
Preferred Qualifications
In‑depth academic knowledge and applied background in clinical research philosophy, with the ability to adapt methods to particular situations and translate research objectives into an operational plan.
In‑depth knowledge of clinical research and drug development concepts, federal, state, and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials.
Additional preferred certifications: Good Clinical Practice (GCP), Collaborative Institutional Training Initiative (CITI), Human Subjects Protection (HSP).
Ability to access intracerebroventricular (ICV) ports and administer investigational products via ICV infusion.
Ability to complete lumbar punctures (LP) and administer intrathecal (IT) investigational products.
Demonstrable record of successfully running complex clinical research trials and designing and implementing quality control, protocol, and quality assurance systems according to accepted clinical standards.
License and Certification
California Registered Nurse (RN) License without restriction.
California Certified Nurse Practitioner (NP) without restriction.
California Nurse Practitioner Furnishing Number including Schedule II furnishing privileges.
NP national board certification from an accepted certifying agency aligned with the patient population and clinical role (Pediatric Outpatient).
California Driver License (if required for position).
Drug Enforcement Administration (DEA) Registration with Schedules 2, 2N, 3, 3N, 4, and 5 registered to a California address.
American Heart Association (AHA) Basic Life Support (BLS) certification.
Additional required AHA certifications: None besides BLS.
Additional required certifications (such as ENLS): None.
Equity Statement
The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.
Salary and Benefits
The final salary and offer components are subject to additional approvals based on UC policy. Placement within the salary range depends on work experience and internal equity for this position classification at UCSF. For positions represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. The benefits program, including total compensation, is available on the UCSF Compensation and Benefits portal.
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