Research Compliance Manager
Teachers College, Columbia University
Job no: 508326
Position type: Staff
Location: New York
The Research Compliance Manager is expected to have in-depth knowledge of and continuing education in federal and state human subjects protections regulations. They will conduct preliminary protocol reviews, route and track all applications to the TC IRB through the College's IRB Axiom Mentor System, and verify exempt research. The responsible person will also conduct reviews in response to allegations and findings of noncompliance with human subjects research and sponsor requirements.
This position serves as primary point of contact for technical assistance concerning the application process, regulatory and administrative guidance, and inquiries about application status. As such, it requires extensive contact with faculty, staff and students.
The person in this position is responsible for ensuring compliance with human subjects protections procedures for all investigators, project staff, students engaged in research, and faculty sponsors on student projects, including:
All aspects of protocol preparation and review and communicating the results of those reviews to researchers
Maintaining all paper and electronic records of the application and review process
Documentation of meeting minutes, records, and forms pertaining to research compliance
Conducting systematic reviews that evaluate researchers' and their study team's compliance with approved protocols
Ensuring compliance with mandated training and certification requirements in human subjects protections for all investigators, project staff, and faculty sponsors on student projects
Compiling reports for audit, monitoring findings, and recommending corrective actions to researchers, as well as reporting findings when appropriate to the IRB Leadership
Receiving and handling compliance issues and complaints, and referring such items, as appropriate
Serving as a compliance resource to the research community and other internal interested parties
Implementation of the College's data security measures
Notifying IRB Leadership and the research community of important research ethics and human subject protection issues as they arise
Monitoring changes in federal regulations and state laws and assessing their impact on research compliance
Provision of guidance to operations staff and IRB members on federal regulations and state laws as required
Responsibilities also include: (1) organization of monthly meetings of the IRB committee comprised of 12 to 15 faculty; (2) coordination of frequent and periodic expedited reviews of protocols (involving 2-3 members of the IRB); and (3) ad-hoc meetings concerning research compliance and quality assurance. As appropriate, the postholder will supervise and guide staff assigned to provide administrative and regulatory support to the IRB.
In conjunction with the Research Compliance Director, the Manager will develop and implement written policies and procedures that foster and enhance compliance in research involving human subjects; generate reports requested by federal agencies; and assist representatives from sponsors and federal agencies conducting audits of human research activities.
The position carries communication and educational functions as well, and the Research Compliance Manager will develop and conduct seminars and lectures, distribute literature, and engage in other programs to educate and facilitate compliance around the College's human research activities.
The position requires interdepartmental interactions which may include a role in oversight and/or education in other areas of research compliance, including conflict of interest, responsible conduct of research, and other emerging areas in the field.
Core Competencies Necessary for Success
Active Listening — Giving full attention to what other people are conveying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
Communication — Clearly conveying information and ideas through a variety of mediums (verbally and online) to individuals or groups in a manner that engages the audience and helps them understand and retain the message. Can create teachable moments.
Comprehension & Process Knowledge — Excellent project management and proven ability to plan and prioritize work to meet commitments needed to achieve results. Strong working knowledge of research process and procedures and experience working as part of an integrated team.
Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to situations.
Decision-Making & Problem-Solving — Demonstrated ability to manage workflow and communication with researchers and administrators, faculty and students. Manages problems that emerge and resolve issues within the work environment.
Initiating Action — Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive. Can take constructive feedback and applying it appropriately.
Organized & Detail-Oriented — Excellent organizational skills, document creation, and computer and database management skills to support the online/offline review of protocols and training.
Ability to prioritize and handle multiple tasks simultaneously, including the ability to work with researchers facing strict deadlines for submission of proposals.
To apply for the position, please visit: https://employment.tc.columbia.edu/cw/en-us/job/508326/research-compliance-manager
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