Clinical Research Operations Lead

Albert Einstein College of Medicine; New York (NY); On-site; USD 47,000 - 49,000; Full time

Job summary

Albert Einstein College of Medicine seeks a capable research coordinator to independently manage study operations, ensure protocol and regulatory compliance, and support sponsor expectations across all phases of clinical research.

You will oversee participant recruitment, enrollment, retention, data management, QA, audits, adverse event reporting to IRB, and collaboration with investigators, sponsors, and the coordinating center. Budget oversight and manuscript contributions are included.

Qualifications

• Bachelor's degree in Public Health, Biological Sciences, Health Sciences, Nursing, Psychology, Social Sciences, or a related scientific discipline.
• 3–5 years of progressive responsibility coordinating or managing clinical research, research administration, or sponsored research programs.
• Knowledge of human subjects research, regulatory compliance requirements, Good Clinical Practice (GCP), and data management principles.
• Experience interpreting research protocols and exercising independent judgment in coordinating complex research activities.
• Ability to manage multiple projects, analyze information, resolve problems, and communicate effectively with investigators, sponsors, regulatory agencies, and research participants.

Responsibilities

• Independently manage and oversee research study operations to ensure compliance with study protocols, regulatory requirements, institutional policies, and sponsor expectations.
• Coordinate participant recruitment, enrollment activities, retention strategies, and study completion.
• Develop, implement, and maintain study tracking systems to monitor enrollment goals, protocol adherence, and study performance.
• Serve as the operational lead for day-to-day study activities, identifying risks and resolving issues.
• Oversee study data management activities, ensuring accuracy and compliance with protocols.
• Conduct quality assurance reviews and data validation; investigate discrepancies and implement corrective actions.
• Coordinate randomization procedures and ensure proper implementation of study interventions.
• Prepare and present progress reports and compliance updates for investigators, sponsors, and leadership.
• Maintain regulatory documentation and study records; readiness for audits and monitoring visits.
• Ensure adverse events and protocol deviations are submitted to the IRB.
• Lead study-related meetings and coordinate follow-up actions with stakeholders.
• Assist PI with protocol amendments for the IRB and manuscript development for publications.
• Train staff and students on data collection and entry; manage data import/export.

Skills

Clear communication

Microsoft Office

Attention to detail

Multitasking

Project planning

Team collaboration

Education

Bachelor's degree in Public Health/Biological Sciences/Health Sciences

Tools

Microsoft Office

Job description

Albert Einstein College of Medicine seeks a capable research coordinator to independently manage study operations, ensure protocol and regulatory compliance, and support sponsor expectations across all phases of clinical research.

You will oversee participant recruitment, enrollment, retention, data management, QA, audits, adverse event reporting to IRB, and collaboration with investigators, sponsors, and the coordinating center. Budget oversight and manuscript contributions are included.