Clinical Research Nurse Practitioner

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Work with the Principal Investigator or other Sub/Co-Investigator on clinical research trials
• Aid in the implementation and execution of clinical study protocols
• Absorb compliance with 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)
• Collaborate with sponsors to clarify acceptable trial activities for a Nurse Practitioner
• Carry out 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. 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
• Provide direct FNP care necessary to research study patients to perform the above functions, including but not limited to:
• 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
• Offer 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
• Document and report 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

QUALIFICATIONS

• 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

EDUCATION AND EXPERIENCE

• Licensed Nurse Practitioner in the state of California
• 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

LANGUAGE SKILLS

• 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
• An understanding of and ability to communicate in scientific language is desired

PHYSICAL DEMANDS

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
• 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

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
• Retail: 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