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Clinical Research Nurse Practitioner
2 months ago
Salary: $63.85 per 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 that necessitate the oversight of a physician or advanced practice medical provider. Flexibility in work hours is essential to accommodate project demands and provide support during the Principal Investigator's absence, which may include evening and weekend hours.
Specific Responsibilities Include:
- Collaborating with the Principal Investigator or other Sub/Co-Investigators on clinical research trials.
- Assisting in the implementation and execution of clinical study protocols.
- Ensuring adherence to protocol requirements as mandated by sponsors, Standard Operating Procedures (SOPs), local and/or central Institutional Review Boards (IRB), and the U.S. Food and Drug Administration (FDA).
- Working with sponsors to clarify acceptable trial activities for Nurse Practitioners.
- Conducting 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, in coordination with the Principal Investigator.
- Being on call as necessary for clinical research subjects in collaboration with the Principal Investigator.
- Providing direct Family Nurse Practitioner (FNP) care to research study patients, which includes:
- Performing medical tests alongside registered nurses, including 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, promptly notifying the Principal Investigator as needed.
- Educating study patients to ensure understanding of medication dosage, administration, and disease management.
- Addressing any medical concerns raised by sponsors, IRB, or FDA related to specific clinical trials.
- Continuing education on the roles and responsibilities of a research Sub-Investigator and completing any required training by sponsors, IRB, or FDA.
- Performing other duties as assigned.
SUPERVISORY ROLE
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 candidate must demonstrate the ability to perform each essential duty satisfactorily. Training will be provided as necessary, and specific assistance will be offered to refresh the candidate in relevant areas. The following qualifications are essential:
- Knowledge and skills required of 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 oral 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 settings is advantageous.
LANGUAGE REQUIREMENTS
Proficiency in reading, writing, and speaking English is mandatory. The ability to interpret documents such as safety rules, SOPs, and procedures is critical, along with an understanding of scientific language.
PHYSICAL DEMANDS
The physical demands of this position require the employee to sit, talk, hear, and climb stairs regularly. Frequent use of hands for handling equipment, papers, or files is necessary. The employee must be able to stand, walk, and reach with hands and arms, occasionally lifting or moving up to 10-20 pounds. Specific vision abilities required include close vision.
This role necessitates manual dexterity, skill, and adequate vision to record data accurately, as well as sufficient hearing and verbal communication skills to interact with study subjects. Standing for extended periods and light lifting may be required.
The incumbent must maintain overall health to report for work consistently and reliably, working through a standard day with appropriate breaks.
WORK ENVIRONMENT
The work environment is primarily an office setting with adjacent clinical facilities and laboratory areas on different floors. Movement within these areas may be necessary to perform job functions. Reasonable accommodations will be made for individuals with disabilities to fulfill essential functions. The noise level is typically moderate, with illumination provided mainly by fluorescent lighting.
This position involves exposure to biohazardous materials and communicable diseases, necessitating the use of universal precautions at all times, along with other conditions common to medical clinics and research facilities.
This job description aims to outline the general requirements for the position. It is not an exhaustive list of duties, responsibilities, or qualifications. Additional tasks may be assigned as needed.
