Clinical Research Coordinator: Study Operations & IRB Support

tuftsmedicine; United States; On-site; USD 55,000 - 85,000; Full time

Job summary

Tufts Medicine is seeking a Clinical Research Assistant to support planning and implementation of clinical studies under a Principal Investigator. The role involves recruitment, data collection, regulatory compliance, and coordination of study activities.

The candidate will ensure adherence to HIPAA, GCP, IRB requirements, and protocol specifics while maintaining accurate records and communicating effectively with the study team.

Qualifications

• Bachelor's degree or equivalent + 4 years related experience.
• BLS certification may be required based on role requirements.
• Two years in research-related activities preferred.
• IATA Hazardous Goods Shipping certification preferred.
• CITI Human Research Protection certification preferred.

Responsibilities

• Assists in recruiting study participants.
• Completes follow-up with participants in prescribed settings.
• Performs record abstraction of source documents and completes CRFs.
• Monitors regulatory binders, case report forms and source documents.
• Assists with IRB requirements including amendments and annual reviews.
• Performs basic laboratory activities as needed.
• Maintains patient confidentiality per HIPAA and adheres to GCP guidelines.
• Coordinates resolution of data queries and reports results to investigator.
• Arranges tests and procedures per protocol requirements.
• Participates in site visits to review documentation.

Skills

Organizational skills

Data collection

Attention to detail

Word processing

Prioritization

Communication

Record-keeping

Education

Bachelor's degree

High School Diploma or equivalent

Tools

Computer literacy

Job description

Tufts Medicine is seeking a Clinical Research Assistant to support planning and implementation of clinical studies under a Principal Investigator. The role involves recruitment, data collection, regulatory compliance, and coordination of study activities.

The candidate will ensure adherence to HIPAA, GCP, IRB requirements, and protocol specifics while maintaining accurate records and communicating effectively with the study team.