Remote Clinical Operations Lead & CRA Oversight

Alimentiv; Newark (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Bonus

Job summary

Alimentiv is seeking a Clinical Operations Leader to oversee a project on a regional/global scale, coordinating CRAs and Investigator sites while ensuring compliance with GCP, ICH guidelines and local regulations. The role acts as the primary liaison between CRAs and the clinical project team and supports training, monitoring plans, and visit scheduling.

Responsibilities include establishing enrollment strategies, tracking performance metrics, reviewing reports, and guiding site management.

Qualifications

• College diploma/degree with 7–9 years related experience or undergraduate degree with 4–6 years’ experience.
• Health Sciences, Life Sciences or Nursing preferred; SoCRA/ACRP certification/designation

Responsibilities

• Provide overall custody and oversight of regional CRA activities to ensure protocol adherence, regulatory compliance and study timelines.
• Conduct CRA training and assessments, and implement enrollment and recruitment strategies.
• Develop monitoring plans and study tools; review visit reports and protocol deviations; ensure timely project deliverables.
• Coordinate line management and communications among CRAs and the clinical project team.
• Oversee startup, feasibility activities and vendor management as required.
• Maintain high-quality documentation and contribute to financial project management processes.

Skills

GCP knowledge

Project oversight

Communication skills

MS Office

EDC systems

Site coordination

Education

College degree

Bachelors degree

Tools

EDC systems

MS Office

Job description

Alimentiv is seeking a Clinical Operations Leader to oversee a project on a regional/global scale, coordinating CRAs and Investigator sites while ensuring compliance with GCP, ICH guidelines and local regulations. The role acts as the primary liaison between CRAs and the clinical project team and supports training, monitoring plans, and visit scheduling.

Responsibilities include establishing enrollment strategies, tracking performance metrics, reviewing reports, and guiding site management.