Regulatory Coordinator - Infectious Diseases

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Salary Range: $67,500 - $79,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $67,500 - $79,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Columbia University Division of Infectious Diseases is seeking a Regulatory Affairs Coordinator to join its research team. The candidate will provide regulatory oversight and support for clinical research related regulatory matters at the Columbia P&S Clinical Research Site (Columbia CRS). Studies conducted at the Columbia P&S CRS include studies sponsored by the National Institutes of Health, investigator-initiated studies as well as numerous industry studies in several areas: treatment and prevention of HIV, sexual health and other infectious diseases of public health importance, as well as community-based and implementation studies in area of COVID-19, HIV, sexual health etc. This position presents opportunities for professional development.

Responsibilities

• Coordinate protocol submission to relevant review committees including but not limited to the Columbia IRB
• Ensure that all regulatory files and protocol approvals are up-to-date
• Maintain regulatory documents and files in support of all research related protocols
• Communicate with various departments and the IRBs
• Communicate with the study sponsors around protocol registration, maintenance and close-out
• Assist with development of standards operating procedures and study materials
• Work with clinical and laboratory staff to support study implementation and study conduct
• Candidate will perform additional related administrative duties as assigned to support study success

Minimum Qualifications

• Bachelor's degree and 3 years of relevant experience or equivalence in experience, education and training

Preferred Qualifications

• Experience in clinical research
• Knowledge of a variety of computer and software applications (Microsoft office, REDCap, electronic data entry systems i.e. Medidata).
• Excellent writing, communication and organizational skills

Other Requirements

• Attention to detail, ability to manage time effectively and strong organizational, and decision-making skills.
• Ability to handle confidential information and maintain confidentiality according to HIPAA.
• Orientation to detail, ability to maintain accurate records, and handle multiple projects and interact with staff at all levels is required. Ability to work independently with minimal supervision is essential.
• Fluency in Spanish

Equal Opportunity Employer / Disability / Veteran

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