• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $62,400.00 - $67,000.00

Position Summary

We are seeking a clinical research coordinator for the pediatric neurology clinical research center at Columbia University Medical Center. The candidate will report to the respective PI's of the studies under consideration, and provide support in guiding, shaping, and executing neurodevelopmental disorder research initiatives related to genetically identified disorders such as autism spectrum disorder and intellectual disability.

Responsibilities

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 Neurology Neurodevelopmental Research Center. In addition, the candidate will be responsible for the following:

• 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 Research Network related activities including telephone and in-person meetings.
• Prepare monthly minutes and quarterly reports.
• Responsible for assisting with grant writing and design for projects, data analysis, preparation of original articles for publication, or presentation at conferences.

Minimum Qualifications

• Requires a bachelor's degree or equivalent in education and experience.

Preferred Qualifications

• The candidate should be highly motivated, interested in genetic neurodevelopmental disorders, 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. Computer skills are required including proficiency with MS-Word, MS-Excel, Outlook, and MS-PowerPoint.  
• The candidate should have experience with database entry, preferably Redcap, however any database entry experience is appropriate.

Equal Opportunity Employer / Disability / Veteran

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