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Clinical Research Nurse II
3 months ago
In close collaboration with the Principal Investigator and Director, Clinical Research Operations, incumbent will serve as a Registered Nurse on various clinical research studies and will assist the Clinical Research team in training staff on clinical and medical aspects of conducting clinical trials. The incumbent will assist with and at times oversees daily operations of clinical nursing and research staff and participates in many aspects of the organization to ensure uniform delivery of quality services and care. Work hours need to be flexible and may include overnight and weekend hours to accommodate individual trial needs. While some remote work may be acceptable at times, this is a primarily in-person position.
This position will fulfill the following specific functions:
- Work with the principal investigator or other co-investigator for clinical research
- 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)
- Providing nursing care to research study patients:
- Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine eligibility requirements for each study
- Performs medical tests, including but not limited to vital signs, imaging studies, electrocardiograms, IV line insertion, and blood draws
- Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects and notifies Principal Investigator accordingly
- Provide education and information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment
- Documents medical and study data appropriately in patient charts/source documents to capture study requirements
- Provide expertise, guidance, and training to nursing and non-medical clinical research staff on clinical aspects of conducting studies, including fingerstick blood glucose/ketone testing, IV troubleshooting, infection control techniques, patient care, and other topics and clinical procedures as needed
- Conducts skills/competency assessments of per diem nursing staff upon hire and annually as appropriate
- Calculates and maintains adequate inventory of research study and clinical supplies
- Oversees the functions of laboratory services including lab specimen collection, handling, and processing as appropriate and adherence to appropriate handling precautions and techniques
- Maintains updated and accessible safety information for all staff. This includes but is not limited to emergency action plans, evacuation procedures, and any safety-related SOP documents
- Participates in the planning, development, delivery, evaluation, and improvement of site policies and procedures to ensure uniform delivery of services, including but not limited to safety planning SOPs, proper use and maintenance of equipment, and proper delivery of patient care, skills assessments, etc.
- Facilitates efficient operations by acting as a mentor and as an education resource for staff
- Contributes to an environment of continued education and learning, keeping staff informed of current information regarding changes in clinical practice and services
- Establishes a positive work environment and promotes positive reinforcement. Advocates for staff and address any issues or concerns with action plans and solutions
- 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.
- Expert at starting IVs, pediatric experience highly desirable
- 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.
- 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.
- Current RN license
- Bachelor of Science in Nursing or other scientific disciplines desired
- Experience in clinical research settings desired
LANGUAGE SKILLS
The ability to read, write and speak English clearly is required. 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 requiring the use of universal precautions at all times as well as other conditions common to a medical clinic and research facility.
This job description 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.
