| Advertised Summary Job Description: We are seeking a Clinical Research Coordinator II (RN) for the pediatric neuromuscular clinical research center at Columbia University Medical Center. The candidate will report directly to the Director of the Program, and provide support in guiding, shaping, and executing neuromuscular disease clinical and research initiatives related to a number of diseases. Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMD) clinical trials currently are the signature initiatives of the research portfolio. 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, 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, 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.
- Coordinate Pediatric Neuromuscular Clinical Research Network related activities including telephone and in-person meetings.
- Prepare monthly minutes and quarterly reports.
The candidate should be highly motivated, interested in pediatric neuromuscular disease, experienced in the acute critical care in the pediatric population, have excellent interpersonal skills and an interest in academic research. We are looking for someone who can establish good rapport with children and families as well as the clinical, research, and administrative teams. We emphasize the importance of team unity as central to our success. Good writing and communication skills are essential. Computer skills are required including proficiency with MS-Word, MS-Excel, Outlook, and MS-PowerPoint.
General Minimum Qualifications: Requires Bachelor's degree or equivalent in education and experience, plus four years of experience.
Additional Specific Minimum Qualifications: -BSN /Registered Nurse, preferred
- Pediatric Advanced Life Support Certification, required
- Ability to work as part of a team; flexibility, and a positive attitude
- Must be organized; attention to detail is required
- Experience with neuromuscular diseases
- Mastery of spoken and written English required
Preferred Qualifications: Masters level or higher in Public Health or a related field preferred.
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.