Clinical Research Nurse Practitioner
7 days ago
Salary: $63.85/hour
KEY RESPONSIBILITIES
In collaboration with the Principal Investigator and the Director of Clinical Research Operations, the incumbent will function as a Nurse Practitioner and Sub-Investigator on various clinical research initiatives requiring oversight from a physician or advanced practice medical provider. Flexibility in work hours is essential to accommodate project demands, including potential evening and weekend commitments.
This role encompasses the following specific duties:
- Collaborate with the Principal Investigator or other Sub/Co-Investigators on clinical research trials.
- Assist in the implementation and execution of clinical study protocols.
- Ensure adherence to protocol requirements as dictated 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).
- Engage with sponsors to clarify acceptable trial activities for Nurse Practitioners.
- Conduct research activities such as physical examinations, and review and sign off on source documents and case report forms (CRF), including medical history forms.
- Be available on-call for clinical research subjects in coordination with the Principal Investigator.
- Provide direct Family Nurse Practitioner (FNP) care necessary for research study participants, including:
- Performing medical tests alongside registered nurses, such as vital signs, imaging studies, electrocardiograms, IV line insertion, and blood draws.
- Administering investigational medications and conducting patient assessments during clinic visits to monitor for side effects, notifying the Principal Investigator as necessary.
- Educating study patients to ensure comprehension of medication dosage, administration, and disease management.
- Address any medical inquiries raised by the sponsor, IRB, or FDA related to specific clinical trials.
- Engage in ongoing education regarding the roles and responsibilities of a research Sub-Investigator and complete any required training by the sponsor, IRB, or FDA.
- Perform other duties as assigned.
SUPERVISORY RESPONSIBILITIES
This position does not have supervisory responsibilities; however, the Sub-Investigator may guide research staff in medical decision-making during clinical trial activities.
QUALIFICATIONS
The incumbent must demonstrate the ability to perform each essential duty satisfactorily. Appropriate training will be provided as necessary. The following qualifications are representative of the knowledge, skills, and abilities required:
- Knowledge and skills pertinent to licensed Nurse Practitioners in California.
- Basic understanding of accepted clinical research practices, including universal precautions, human subjects research protocols, and HIPAA regulations.
- Ability to work independently with meticulous attention to detail.
- Strong multi-tasking and organizational capabilities.
- Excellent verbal and written communication skills.
- Ability to establish rapport and communicate effectively with subjects from diverse cultural and educational backgrounds.
- Capability to prioritize and delegate tasks while fully participating in clinical research trials.
EDUCATION AND EXPERIENCE
- Licensed Nurse Practitioner in California.
- Interest and experience in diabetes management, including education and care.
- Certification as a Diabetes Educator or Board Certification in Advanced Diabetes Management is preferred.
- Experience in clinical research environments is advantageous.
LANGUAGE SKILLS
Proficiency in reading, writing, and speaking English is mandatory. The ability to interpret documents such as safety rules, SOPs, and procedures is essential, along with a capacity to communicate in scientific terminology.
PHYSICAL DEMANDS
The physical demands outlined here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made for individuals with disabilities.
The incumbent is regularly required to sit, talk, hear, and navigate stairs. Frequent use of hands for handling equipment, paperwork, or files is necessary. The role requires standing, walking, and reaching with hands and arms. The employee may occasionally lift and/or move up to 10-20 pounds. Specific vision abilities required include close vision.
This position necessitates manual dexterity, skill, and adequate vision to accurately record data and effective hearing and verbal communication skills to interact with study subjects. Prolonged standing and light lifting may be required.
The incumbent must maintain sufficient overall health to consistently report for work and manage a standard workday with appropriate breaks.
WORK ENVIRONMENT
The work environment is primarily an office setting with adjacent clinical facilities and laboratory areas on a different floor. Movement within these areas may be necessary to fulfill job responsibilities. Reasonable accommodations may be made for individuals with disabilities. The noise level is typically moderate, with illumination primarily from fluorescent lighting.
This position involves exposure to biohazardous materials and communicable diseases, necessitating adherence to universal precautions at all times, as well as other conditions common to medical clinics and research facilities.
This job description aims to outline the general requirements for the role. It is not an exhaustive list of duties, responsibilities, or qualifications, and additional tasks may be assigned as needed.
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