Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES

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:

1. Work with the Principal Investigator or other Sub/Co-Investigator on clinical research trials
2. Assist with the implementation and execution of clinical study protocols
3. 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)
4. Work with sponsors to clarify which trial activities are acceptable for a Nurse Practitioner to perform
5. 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
6. Be on call as needed for clinical research subjects in coordination with Principal Investigator
7. Providing the direct FNP care necessary to research study patients to perform the above functions, including but not limited to:
   1. Participate in recruitment and selection of study participants to determine eligibility for each study
   2. 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
   3. Administer investigational medications and perform patient assessments during clinic visits to determine presence of side effects and notify Principal Investigator accordingly
   4. Provide education and information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment
8. Provide expertise, guidance, and training to nursing and non-medical clinical research staff on any relevant aspects of conducting studies and providing patient care
9. Participate in the planning, development, delivery, evaluation, and improvement of site policies and procedures to ensure uniform delivery of services
10. Maintain ongoing communication with referring primary care physicians for the research subjects as deemed appropriate for the ongoing care rendered by that physician
11. Be available to answer any questions raised during study monitor visits
12. 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
13. Address any medical concerns raised by the sponsor, IRB, or FDA that relate to specific clinical trials
14. 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
15. Provide nutrition and diabetes education as appropriate
16. Act as a Sub-Investigator on studies across multiple disciplines, including drug, device, and artificial pancreas trials
17. Other duties as assigned

QUALIFICATIONS

The incumbent must be able to perform each essential duty satisfactorily. Appropriate training will be provided where necessary, and specific assistance in refreshing the incumbent in those areas where appropriate. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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 and 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

WORK ENVIRONMENT

The work environment would be generally described as an office setting with clinical facilities adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three of these areas may be required in the execution of the employee's functional activities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate and the illumination of the work area is primarily with fluorescent artificial lighting.

This position is associated with exposure to biohazardous materials and communicable disease always requiring the use of universal precautions as well as other conditions common to a medical clinic and research facility.

This is intended to describe the general requirements of the performance of the job. It is not a complete list of duties, responsibilities or requirements. Other duties not listed here may be assigned as needed.

BENEFITS

Our team consists of diverse and dedicated individuals committed to enhancing the lives of those impacted by diabetes through research, education, and care. Each employee plays a crucial role in advancing our mission, and we are committed to ensuring that everyone feels valued and supported. To achieve this, we offer a comprehensive benefits package for full-time employees, designed to promote professional growth, enhance well-being, and foster a healthy work-life balance.

• 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.

COMPENSATION

The salary range for this role may vary above or below the posted range as determined by education, experience, and specialized certifications. Compensation takes into account several factors including but not limited to a candidate's experience, education, skills, licensure and certifications, department equity, training and organizational needs. Base pay is just one piece of the total rewards program offered by SDRI. Eligible roles also qualify for a comprehensive benefits package.

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