Clinical Research Nurse Practitioner

Sansum Diabetes Research Institute • Santa Barbara, CA

10d • Onsite

About The Position

In close collaboration with and under the supervision of the Principal Investigator and Director, Clinical Research Operations, incumbent will serve as a Nurse Practitioner and Sub-Investigator on various clinical research studies that require the supervision of a physician or advanced practice medical provider. Incumbent will lead the clinical research team in the clinical and medical aspects of conducting clinical trials. Work hours will need to be flexible to meet project needs and to provide support for times when the Principal Investigator cannot be present. Attendance at departmental and general staff meetings is expected. This is an office-based role; consistent, in-person attendance is required and may include occasional overnight and weekend hours to accommodate individual trial needs. This position will fulfill the following specific functions: Work with the Principal Investigator or other Sub/Co-Investigator on clinical research trials Assist with the implementation and execution of clinical study protocols Assure compliance with the protocol requirements as mandated by the sponsor, our Standard Operating Procedures (SOPs), local and/or central Institutional Review Boards (IRB), and the U.S. Food and Drug Administration (FDA) Work with sponsors to clarify which trial activities are acceptable for a Nurse Practitioner to perform Complete research activities such as physical examinations, reviewing and signing off on source documents and case report forms (CRF) including but not limited to review of systems and medical history forms. Incumbent with coordinate with Principal Investigator as needed to ensure adequate coverage of this function Be on call as needed for clinical research subjects in coordination with Principal Investigator Providing the direct FNP care necessary to research study patients to perform the above functions, including but not limited to: Participate in recruitment and selection of study participants to determine eligibility for each study Perform, interpret, and verify accuracy of medical tests in conjunction with registered nurses, including but not limited to vital signs, imaging studies, electrocardiograms, IV line insertion, and blood draws Administer investigational medications and perform patient assessments during clinic visits to determine presence of side effects and notify Principal Investigator accordingly Provide education and information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment Provide expertise, guidance, and training to nursing and non-medical clinical research staff on any relevant aspects of conducting studies and providing patient care Participate in the planning, development, delivery, evaluation, and improvement of site policies and procedures to ensure uniform delivery of services Maintain ongoing communication with referring primary care physicians for the research subjects as deemed appropriate for the ongoing care rendered by that physician Be available to answer any questions raised during study monitor visits Documents and reports any adverse events (AEs) per protocol, IRB, and FDA requirements and document and report any serious adverse events (SAEs) to Principal Investigator and sponsor within 24 hours Address any medical concerns raised by the sponsor, IRB, or FDA that relate to specific clinical trials Continue education on the roles and responsibilities of a research Sub-Investigator as well as complete any training required by the sponsor, IRB, or FDA Provide nutrition and diabetes education as appropriate Act as a Sub-Investigator on studies across multiple disciplines, including drug, device, and artificial pancreas trials Other duties as assigned

Requirements

• Knowledge and skills required of licensed Nurse Practitioners in the state of California
• Basic knowledge of computer systems for word processing, email, data entry, and electronic data transfer
• Basic knowledge of accepted clinical research practices, including universal precautions, human subjects research protocols, and HIPAA requirements
• Ability to work independently and with careful attention to detail as well as work collaboratively with a team
• Ability to independently supervise studies under the guidance of the Principal Investigator
• Excellent multi-tasking and organizational skills.
• Excellent oral and written communication skills.
• Must be able to establish rapport and communicate with subjects of diverse cultural and educational backgrounds.
• Must be able to prioritize and delegate tasks and participate fully in clinical research trials
• Licensed Nurse Practitioner in the state of California
• The ability to read, write and speak English clearly is mandatory.
• The ability to interpret documents such as safety rules, SOPs, and procedures is critical and an understanding of and ability to communicate in scientific language is desired.
• The incumbent is regularly required to sit, talk, hear, and climb stairs.
• The incumbent frequently is required to use hands to finger, handle or feel equipment, paper, or files.
• The incumbent is required to stand, walk, and reach with hands and arms.
• The employee must occasionally lift and/or move up to 10-20 pounds.
• Specific vision abilities required by this job include close vision.
• This position requires manual dexterity, skill level and adequate vision to record data onto data sheets and adequate hearing and verbal communication skills to converse with study subjects.
• Standing for extended periods of time as well as light lifting is necessary.
• The incumbent must be in sufficient overall health to report for work consistently and reliably and work through a standard day with appropriate breaks.

Nice To Haves

• Interest and experience in diabetes desired, including diabetes education and management
• Certified Diabetes Educator or Board Certification in Advanced Diabetes Management desired
• Experience in clinical research setting preferred

Responsibilities

• Work with the Principal Investigator or other Sub/Co-Investigator on clinical research trials
• Assist with the implementation and execution of clinical study protocols
• Assure compliance with the protocol requirements as mandated by the sponsor, our Standard Operating Procedures (SOPs), local and/or central Institutional Review Boards (IRB), and the U.S. Food and Drug Administration (FDA)
• Work with sponsors to clarify which trial activities are acceptable for a Nurse Practitioner to perform
• Complete research activities such as physical examinations, reviewing and signing off on source documents and case report forms (CRF) including but not limited to review of systems and medical history forms.
• Incumbent with coordinate with Principal Investigator as needed to ensure adequate coverage of this function
• Be on call as needed for clinical research subjects in coordination with Principal Investigator
• Participate in recruitment and selection of study participants to determine eligibility for each study
• Perform, interpret, and verify accuracy of medical tests in conjunction with registered nurses, including but not limited to vital signs, imaging studies, electrocardiograms, IV line insertion, and blood draws
• Administer investigational medications and perform patient assessments during clinic visits to determine presence of side effects and notify Principal Investigator accordingly
• Provide education and information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment
• Provide expertise, guidance, and training to nursing and non-medical clinical research staff on any relevant aspects of conducting studies and providing patient care
• Participate in the planning, development, delivery, evaluation, and improvement of site policies and procedures to ensure uniform delivery of services
• Maintain ongoing communication with referring primary care physicians for the research subjects as deemed appropriate for the ongoing care rendered by that physician
• Be available to answer any questions raised during study monitor visits
• Documents and reports any adverse events (AEs) per protocol, IRB, and FDA requirements and document and report any serious adverse events (SAEs) to Principal Investigator and sponsor within 24 hours
• Address any medical concerns raised by the sponsor, IRB, or FDA that relate to specific clinical trials
• Continue education on the roles and responsibilities of a research Sub-Investigator as well as complete any training required by the sponsor, IRB, or FDA
• Provide nutrition and diabetes education as appropriate
• Act as a Sub-Investigator on studies across multiple disciplines, including drug, device, and artificial pancreas trials
• Other duties as assigned

Benefits

• Competitive Salaries : Attractive compensation aligned with industry standards.
• Ongoing Training and Development : Access to programs that promote continuous learning and opportunities for career advancement.
• Health Insurance : 100% employer-paid premiums for the employee's medical (Anthem Platinum level PPO plan), dental, vision, life, and long-term disability insurance plans.
• Dependent Coverage Support : An additional $300 per month towards dependent medical insurance premiums.
• Supplemental Benefits : Opportunities to purchase supplemental life and critical care insurance at a reduced cost.
• Retirement Plan : A 403(b) retirement plan with a discretionary company match to help secure your financial future.
• Generous Paid Time Off : Enjoy 15 vacation days, 11 paid holidays, and 2 floating holidays each year.
• Inclusive Work Environment : Be part of a collaborative workplace that values diversity and inclusion.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed