The Director for Compliance Oversight (DCO) within the Human Research Protection Office (HRPO) of Columbia University (CU) leads the Compliance Oversight Team (COT) within the Human Research Protection Office (HRPO) of Columbia University (CU). The DCO will report to and work closely with the Associate Vice President for Human Research Protection (AVP) to develop and execute a comprehensive and efficient program by which the COT will assess the compliance of active research studies with federal regulations, state law, institutional policy and the protocols as approved by the IRB. The successful candidate will collaborate with the AVP, the Directors for IRB Management and Operations of the HRPO, CU faculty and administration and NewYork-Presbyterian Hospital administration in meeting the institutional needs regarding clinical research monitoring, quality assurance, training and process-improvement goals.
The ideal candidate will possess strong analytical capabilities, solid clinical research experience, management expertise, superior writing skills and an acute attention to detail. The Director will work closely with internal CU units that are involved in research such as Sponsored Projects Administration, the Clinical Trials Office and the Irving Institute for Clinical and Translational Science.
Bachelor’s degree or equivalent and five years of related experience
Experience with clinical monitoring or research compliance in a scientific or healthcare discipline, or managing clinical trials.
Prior management or supervisory experience.
In depth knowledge of federal, state and local laws and regulations and industry requirements and practices regarding the proper conduct of human research.
Poised, mature and professional to work with a variety of personalities within the University, at other research institutions and at federal regulatory agencies.
Demonstrable ability to collaborate with partners in research, i.e., investigators and coordinators.
Excellent written and verbal communication skills, and strong proofreading skills.
Detail oriented, with superior organizational skills and able to manage and prioritize a variety of projects at once.
Resourceful, proactive, and thorough, having a focused, self-starting attitude with the ability to work independently and as a member of the team.
Solid computer skills and strong competency in Microsoft Office products, particularly Excel.
Experience in development and management of a research compliance program
Familiarity with social science, behavioral and humanities research
If you are a motivated professional, passionate about your career, and want to make a difference in the world, Columbia University is the right place for you. Join our community and be at the forefront of innovation.