Advertised Summary Job Description: We are seeking a Pediatric Research Nurse for the pediatric neuromuscular clinical research center at Columbia University Medical Center. The candidate will report directly to Dr. Claudia Chiriboga, Director of the MDA clinical care center and Principal investigator of SMA trials. Candidate's role is to provide support in guiding, shaping, and executing neuromuscular disease clinical and research initiatives related to Spinal Muscular Atrophy (SMA). The candidate will be responsible for subject recruitment, and for providing direction and supervision of operations and research staff. Additional responsibilities include maintaining compliance with existing policies and procedures at Columbia University, the IRB, FDA, NIH, and NYPH that relate to clinical research conducted at the Pediatric Neuromuscular Center and Spinal Muscular Atrophy Clinical Research Center. The candidate will also be responsible for assisting with grant writing and design for projects, data analysis, preparation of original articles for publication, or presentation at conferences. In addition, the candidate will be responsible for the following tasks:
-Protocol and budget evaluations for operational and fiscal feasibility -Participation in pre-study, initiation, monitoring and close out visits -Clinical trial preparation involving the planning, assembling and instruction of the trial team, development and evaluation of patient information and informed consent forms and patient recruitment. -Submission of and adherence to Institutional Regulations and IRB protocols -Implementation of clinical trials from initiation, including development of SOPs and case report forms -Recruitment and coordination of the clinical trial participants covering informed consent, screening, and inclusion of the subjects adhering to safety and compliance issues. -Coordination and management of the clinical trial, communication with sponsor and monitors, visit coordination, sample acquisition and processing. -Carrying out clinical tasks encompassing both, the Neuromuscular Clinic and clinical research protocols including though not limited to the following: monitoring vital signs, collecting and processing blood and other specimens, IV placement (after training) for the purpose of research drug transfusions or PK blood drawings in age appropriate research participants, EKGs, PFTs, etc. -Reporting and documentation of protocol deviations and exemptions as well as development and implementation of corrective action plans for review by the Principal Investigator as needed -Data collection and management, collection of source documents, registration, and management of AEs, special emphasis to SAE's, filing and archiving, managing monitoring visits and managing queries. -Close-out of the clinical trial, contributing to manuscripts, audit preparation, trial completion, and communication with authorities. Other responsibilities include assisting with the final study report and completing financial obligations.
General Minimum Qualifications: Requires a bachelor's of Science degree in Nursing or equivalent in education and experience plus four years of clinical research experience.
Additional Specific Minimum Qualifications: -Must be organized; attention to detail is required -Experience with neuromuscular diseases -Proficient spoken and written English required
Preferred Qualifications: -Pediatric Advanced Life Support Certification, preferred -Ability to work as part of a team; flexibility, and a positive attitude
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
Internal Number: 126_174667
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.