Clinical Research Coordinator: Study Operations & Compliance

Hackensack Meridian Health; Edison (NJ); On-site; USD 72,000 - 88,000; Full time

Job summary

Hackensack Meridian Health is seeking a Clinical Research Coordinator to oversee the clinical operations of assigned trials, coordinating with investigators, nurses, and staff to ensure compliant conduct under local, state, and federal regulations.

The role involves budgeting, study documentation, enrollment oversight, and coordinating tests and site visits, with emphasis on accuracy and regulatory compliance.

Qualifications

• BA/BS diploma/degree in science or healthcare field.
• Minimum 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in clinical research.
• Strong attention to detail and customer service focus.
• Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
• Excellent organizational, presentation, documentation and interpersonal skills.
• Excellent written and verbal communication skills.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Responsibilities

• Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
• Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.
• Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens.
• Maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required.
• Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit.

Skills

Attention to detail

Customer service

Independent worker

Organizational skills

Communication skills

Education

BA/BS in science or healthcare

2+ years in Senior Clinical Data Coordinator/Regulatory role

Tools

Microsoft Office/Google Suite

Job description

Hackensack Meridian Health is seeking a Clinical Research Coordinator to oversee the clinical operations of assigned trials, coordinating with investigators, nurses, and staff to ensure compliant conduct under local, state, and federal regulations.

The role involves budgeting, study documentation, enrollment oversight, and coordinating tests and site visits, with emphasis on accuracy and regulatory compliance.