| Job Title | Clinical Research Coordinator |
| Job Code Title | |
| Job Requisition Number | 076807 |
| Department | 7524- NEU Neurology |
| Location | Medical Center |
| Job Type | Officer Full-Time Regular |
| Bargaining Unit | |
| If temporary, indicate duration | |
| Hours Per Week | 35 |
| Job Family | Research Support (Laboratory and Non-Laboratory) |
| Salary Grade | 103 |
| Salary Range | |
| Advertised Summary Job Description | We are seeking a clinical research coordinator 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 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. * 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, 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. |
| Minimum Qualifications for Grade Applicant MUST meet these minimum qualifications to be considered an applicant | * Bachelor's Degree and at least two years' related experience, or an equivalent combination of education and experience. |
| Additional Position-Specific Minimum Qualifications Applicant MUST meet these minimum qualifications to be considered an applicant | * At least 2 years of experience in a clinical trials setting. * 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. * Excellent verbal and written communication skills and attention to detail required. * Ability to work independently required. |
| Preferred Qualifications | * Master's Degree. |
| Special Instructions | |
| Special Indications This position works with: | Contact with patients and/or research subjects |
| HIPAA Compliance training required | Yes |
| Participation in Medical Surveillance required | Yes |
| What type of posting? Is this a waiver request? | Standard Posting |
| Requisition Open Date | 01-23-2014 |
| Requisition Close Date | Open Until Filled |
| Quick Link | jobs.columbia.edu/applicants/Central?quickFind=146432 |
| EEO Statement | Columbia University is an Equal Opportunity/Affirmative Action employer. |
| Local Hiring | Columbia University is committed to the hiring of qualified local residents. |
Wednesday, January 28, 2015
Columbia University NY Pediatric Neuromuscular Research
