Clinical Research Operations Lead

Mount Sinai Morningside; New York (NY); On-site; USD 79,000 - 144,000; Full time

Job summary

The Mount Sinai Morningside health system seeks an Assistant Director to support the Director in managing the department’s administrative, operational, financial, and clinical research activities. You will supervise staff, coordinate budgeting and regulatory compliance, and optimize study operations and vendor relationships to ensure successful trials.

Collaborating with faculty, sponsors, CROs, and internal departments, you will support strategic planning and growth within a large academic

Qualifications

• Bachelor's Degree in Health Care Administration, Public Administration, Business Administration, Life Sciences, Clinical Research, or a related field; master’s degree preferred.
• Clinical research or project-management certification is preferred.
• 5 years minimum experience, preferably in a hospital, academic medical center, health care, clinical research, or related environment.
• Experience in clinical research operations, departmental administration, budgeting, regulatory activities, or project management preferred.
• Supervisory, team-lead, or staff-coordination experience preferred.
• Experience working with a contract research organization, pharmaceutical company, biotechnology company, academic research organization, or clinical research sponsor preferred.
• Experience with clinical trial management systems, electronic data-capture and regulatory platforms, financial and contract-management systems, research

Responsibilities

• Support the Director in day-to-day operational, administrative, financial, and clinical research activities to ensure efficient operations.
• Coordinate departmental workflows, staff assignments, operational priorities, and resources to support clinical trials, research initiatives, and administrative operations.
• Assist with recruitment, onboarding, supervision, mentoring, training, and performance management of administrative and research staff while promoting a collaborative work environment.
• Coordinate clinical research studies and operational activities, ensuring compliance with study protocols, sponsor requirements, institutional policies, and regulatory guidelines.
• Support regulatory compliance by coordinating regulatory documentation, submissions, quality assurance activities, audit readiness, and corrective action plans, as needed.
• Monitor study timelines, enrollment, operational metrics, and project milestones, communicating progress, identifying issues, and assisting with timely resolution.
• Assist with departmental and study budgets by tracking expenses, reconciling financial activity, preparing reports, and coordinating with Finance and other institutional departments.
• Coordinate communications and activities with investigators, sponsors, CROs, vendors, consultants, and internal departments to support departmental and research operations.
• Prepare reports, presentations, dashboards, and operational metrics to support leadership decision-making and continuous process improvement.
• Participate in departmental meetings, committees, and special projects, and perform other related duties as assigned.

Skills

Regulatory knowledge

Communication skills

Analytical skills

Project management

Multitasking

Education

Bachelor's degree in Health Care Administration

Master’s degree preferred

Tools

Clinical trial management systems

Electronic data capture systems

Financial/contract management systems

Regulatory platforms

Job description

The Mount Sinai Morningside health system seeks an Assistant Director to support the Director in managing the department’s administrative, operational, financial, and clinical research activities. You will supervise staff, coordinate budgeting and regulatory compliance, and optimize study operations and vendor relationships to ensure successful trials.

Collaborating with faculty, sponsors, CROs, and internal departments, you will support strategic planning and growth within a large academic