- Job Type: Officer of Administration
- Bargaining Unit:
- Regular/Temporary: Regular
- End Date if Temporary:
- Hours Per Week: 35
- Standard Work Schedule:
- Building:
- Salary Range: $135,000.00 - $145,000.00
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
The Kaler Laboratory in the Department of Pediatrics is seeking a Clinical Research Nurse Practitioner to join our team in a full-time position to plan and conduct FDA-regulated clinical research related to adeno-associated virus (AAV) gene therapy and other experimental therapeutics for inherited neurometabolic diseases.
At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. We apply the same rigor in our commitment to fostering an inclusive, thriving community and caring for our employees and their loved ones. We offer immediate eligibility and invest in our employees' families through comprehensive Health and Welfare, Employee Assistance, Tuition Programs, and Retirement Benefits.
"Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process"
Responsibilities
- Develops and writes clinical trial protocols on inherited pediatric illnesses, in concert with the investigative team, to evaluate experimental therapeutic interventions, including viral gene therapy.
- Applies outstanding ability in scientific writing with specific strengths in protocol mapping, manuscript preparation, and patient care to the laboratory's clinical research mission.
- Interacts with the CUIMC institutional review board (IRB) in the initial and ongoing approvals of clinical trial protocols.
- Helps establish Data Safety Monitoring Committees (DSMC) for individual clinical trials and oversees DSMC activities, meetings, and interactions with the investigative team.
- Coordinates clinical trial subject screening and enrollment in conjunction with the investigative team.
- Performs inpatient and outpatient assessments of clinical trial participants including collection of initial and interval medical histories, and review of possible adverse events.
- Oversees emerging clinical trial data, including physician examination results, biochemical findings and assesses adverse events.
- Completes and reviews case report forms from clinical trial participant visits.
- Obtains feedback from clinical trial participants and their parents and ensures travel and lodging reimbursement, when appropriate.
- Assists the principal investigator in overall coordination and oversight of the projects.
- Performs related duties & responsibilities as requested.
Minimum Qualifications
- Requires Master's degree or equivalent in education and experience, plus two years of related experience.
Other Requirements
- Current NYS NP License, maintain and renew when necessary. (NP's are Required to have a NYS license to qualify for the position).
- Current NYS RN License.
- NP Board Certification.
- DEA License.
- BCLS and ACLS certification.
- Able to meet New York-Presbyterian Hospital credentialing requirements.
Preferred Qualifications
- Extensive experience (> 10 years) in a clinical research setting, with a minimum of 4-6 years' experience in managing viral gene therapy protocols.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.