"Senior Research Regulatory Coordinator"

Position Summary

The Senior Research Regulatory Coordinator will report to the Chief of the Division and will be responsible for managing the day-to-day operations of the research program. This role involves strategic planning, coordination, and implementation of all project components to ensure the successful execution of study objectives. This position has responsibility across three entities: Columbia University Department of Psychiatry (CU DOP), Research Foundation for Mental Hygiene (RFMH) and New York State Psychiatric Institute (NYSPI).

The Senior Research Regulatory Coordinator holds primary responsibility for managing the group’s regulatory, documentation, and reporting functions. This includes developing and implementing standard operating procedures (SOPs), guidance documents, and training materials to support research staff.

Responsibilities

• Prepare and submit IRB protocols for approvals of research studies, Prepare monthly NIA Croms enrollment update, keeping up to date Regulatory Binder 20%
• Train, supervise and coordinate the work of research assistants and volunteers 20%
• Setting up Standard Operational Manuals for new studies 10%
• Ability to juggle multiple, competing priorities in a fast-paced, complex environment with limited direction and with superior attention to detail. Superior professional interpersonal management skills, with demonstrated ability to work both in a team and independently 10%
• Must be meticulous in carrying out research protocols and be able to maintain a high level of accuracy with minimal supervision 10%
• Assist with and coordinate the preparation of presentations, reports 10%
• Review patient binders to ensure they have all the require forms 10%
• Liaising between PIs/project teams as needed to support troubleshooting 5%
• Performs related duties & responsibilities as assigned/requested 5%

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience required, 4 years related experience.

Preferred Qualifications

• Knowledge of University systems, such as CU Rascal.
• Clinical Trials.
• WCG/Advarra.
• Shows strong initiative and operates effectively with limited direction.

Other Requirements

• Must successfully complete all online systems training requirements.
• Research Program management experience.
• Experience developing, submitting, and/or administering IRB proposals.
• Exceptional time management, prioritization, and organizational skills.