Director,Clinical Research Ops - The Trustees of Columbia University in the City of New York

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule: M-F 9am-5pm
• Building: Neurological Institute
• Salary Range: $140,000 - $160,000

Position Summary

The Director of Clinical Research Operations is responsible for overseeing and managing all aspects of clinical research activities at the medical center. This role ensures that clinical trials and research projects are conducted in compliance with regulatory standards, institutional policies, and ethical guidelines. The Director will work closely with clinical teams, investigators, regulatory bodies, and sponsors to lead the research strategy and contribute to the advancement of medical knowledge and patient care.

Responsibilities

• Leadership and Strategy: Develop and implement the overall clinical research strategy for the department under the direction of the Vice Dean of Research and Department Chair. Collaborate with leadership to identify research opportunities aligned with institutional goals. Lead the clinical research team, providing mentorship, supervision, and development opportunities.
• Directly oversee the recruitment, mentorship, training and performance of research personnel including clinical research coordinators and regulatory coordinators
• Clinical Trial Oversight: Manage the full life cycle of clinical trials, including protocol development, regulatory submissions, patient recruitment, data collection, analysis, and reporting. Ensure all clinical research activities comply with Good Clinical Practice (GCP), FDA regulations, IRB guidelines, and other relevant standards. Oversee budget development, grant applications, and funding opportunities for research projects
• Regulatory Compliance: Ensure compliance with all regulatory requirements, including Institutional Review Board (IRB) approvals, informed consent processes, and adverse event reporting. Maintain accurate documentation and ensure adherence to clinical trial protocols and institutional policies. Serve as a point of contact for regulatory agencies, sponsors, and auditors during clinical trial inspections and reviews
• Collaboration and Stakeholder Engagement: Work with physicians, researchers, and external partners to design, implement, and manage clinical studies
• Quality Assurance and Improvement: Implement and monitor quality assurance measures to ensure the integrity and validity of clinical research data. Continuously evaluate and improve research processes, workflows, and systems to enhance efficiency and compliance. Identify areas for improvement in research infrastructure, technology, and staff development
• Implement divisional and departmental clinical research training programs engaging faculty and research administration
• Patient and Participant Engagement: Oversee the recruitment, enrollment, and retention of research participants. Ensure patient safety, rights, and confidentiality are prioritized throughout the research process. Coordinate with clinical staff to provide optimal care for research participants and address any concerns or complications
• Budgeting and Resource Management: Develop and manage budgets for clinical research projects, ensuring efficient allocation of resources. Monitor expenditures and ensure projects are completed within budget and on time. Seek additional funding sources, such as grants or industry-sponsored research agreements
• Other duties as assigned

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience, plus five years of related experience

Preferred Qualifications

• Education: Advanced degree in a health-related field (e.g., nursing, pharmacy, public health)
• Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and/or SOCRA
• Experience: 3-5 years in a leadership or managerial role. Proven track record of successful clinical trial management, from design to completion. Experience with regulatory submissions, grant writing, and contract negotiation
• Skills: Strong understanding of FDA regulations, GCP, IRB processes, and clinical research methodologies. Excellent leadership, organizational, and communication skills. Ability to manage multiple projects simultaneously and work in a fast-paced environment. Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC), and research databases

• Strategic thinking and problem-solving
• Ethical judgment and decision-making
• Attention to detail and quality
• Team collaboration and leadership