• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Salary Range: Commensurate with experience

Position Summary

We are seeking a Clinical Research Coordinator for the Pediatric Neuromuscular Clinical Research Center at Columbia University Medical Center. The candidate will report to the Principal Investigator of the studies under consideration, and provide support in executing neuromuscular disease research initiatives related to a number of diseases. Spinal Muscular Atrophy, Duchenne Muscular Dystrophy (DMD), Glut1 Deficiency clinical trials, and a Mitochondrial disease natural history study currently are the signature initiatives of the research portfolio.

Responsibilities

The candidate will be responsible for coordinating with subject recruitment, 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. 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 assisting the following:

• Participation in pre-study, initiation, monitoring and close out visits
• Assist in clinical trial preparation involving the planning, assembling and instruction of the trial team, development and evaluation of patient information and informed consent forms, patient recruitment and inclusion of the subjects adhering to safety and compliance issues.

• Assist with implementation of clinical trials from initiation, including development of SOPs and case report forms.

• 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.

• Carry out trial protocol including communication with sponsor and monitors, arranging of study visits, sample acquisition and processing, and completing subject reimbursements.

• Data collection and maintenance, collection of source documents, registration, and management of AEs, filing and archiving, managing monitoring visits and managing queries.

• Assist in close-out of clinical trials, contributing to manuscripts, audit preparation, trial closure, and communication with authorities other disciplines involved, assisting with the final study report and completing financial obligations.

• Assist in coordinating Pediatric Neuromuscular Clinical Research Network related activities including telephone and in-person meetings.
• Prepare monthly minutes and quarterly reports.
• Assist with weekly Pediatric Neuromuscular Research Center Clinic Visits where appropriate, such as assisting with the administration of Pulmonary Function Testing and the Six Minute Walk Test.
• Other responsibilities as assigned. 

Minimum Qualifications

• Requires a bachelor's degree or equivalent in education and experience, plus two years experience.
• Must successfully complete systems training requirements.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.