Clinical Research Nurse Practitioner

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:

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

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…