Clinical Research Operations Lead

Einstein

New York (NY)

On-site

USD 47,000 - 49,000

Full time

10 days ago

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Job summary

Albert Einstein College of Medicine is seeking a Research Coordinator to ensure compliance with institutional policies, federal and state regulations, and sponsor requirements. The role supports junior faculty career development and drives academic initiatives within the division.

You will independently manage study operations, oversee recruitment and enrollment, monitor milestones, and maintain regulatory documentation for audits and IRB submissions.

Qualifications

  • Bachelor's degree in Public Health, Biological Sciences, Health Sciences, Nursing, Psychology, Social Sciences, or 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 coordinating complex research activities.
  • Ability to manage multiple projects, analyze information, resolve problems, and communicate effectively with investigators, sponsors, regulatory agencies, and participants.

Responsibilities

  • Independently manage and oversee research study operations to ensure compliance with protocols and regulations.
  • Coordinate recruitment, enrollment activities, retention strategies, and study completion.
  • Analyze eligibility data and facilitate enrollment decisions with investigators.
  • Develop and maintain study tracking systems for enrollment goals and milestones.
  • Serve as operational lead for day-to-day study activities and resolve issues.
  • Ensure regulatory compliance and adherence to protocols across study activities.
  • Oversee data management and ensure data quality and governance compliance.
  • Coordinate randomization procedures and proper implementation of interventions.
  • Prepare and present study progress reports and compliance updates.
  • Maintain regulatory documentation and readiness for audits and reviews.
  • Ensure adverse events and protocol deviations are reported to IRB.
  • Lead study meetings and coordinate priorities and follow-ups.
  • Collaborate on study protocols and amendments for IRB.
  • Assist with abstracts, presentations, and manuscripts.
  • Partner with IT to develop databases and data entry guidelines; train staff.
  • Manage data collection from diverse formats for rapid dissemination to PIs and sponsors.
  • Support junior faculty career development activities.
  • Work with Departmental Administrator on project budgets.
  • Identify opportunities to improve efficiency, data quality, and regulatory compliance.
  • Perform other research administration and project management duties.

Skills

MS Office
Communication skills
Teamwork
Attention to detail
Time management

Education

Bachelor's degree in Public Health or related field

Tools

Regulatory databases
Data management systems

Job description

Albert Einstein College of Medicine is seeking a Research Coordinator to ensure compliance with institutional policies, federal and state regulations, and sponsor requirements. The role supports junior faculty career development and drives academic initiatives within the division.

You will independently manage study operations, oversee recruitment and enrollment, monitor milestones, and maintain regulatory documentation for audits and IRB submissions.

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