Senior Clinical Trials Coordinator

South Shore Health; United States; On-site; USD 62,000 - 89,000; Full time

Job summary

South Shore Health in Weymouth, MA is seeking a Senior Clinical Research Coordinator to support the clinical trials program under the Principal Investigator and Clinical Research Manager. You will lead data collection, management of patient information, and ensure protocol compliance across trials.

The role may involve IRB submissions, regulatory binder maintenance, and occasional travel. Strong organization and communication skills are essential for success in this on-site position.

Qualifications

• Bachelor’s degree preferred or 1 year required in a scientific field.
• 3–5 years of experience in a medical or scientific research setting or comparable technology-oriented business environment preferred.
• Excellent organization and communication skills; detail oriented; able to manage time and priorities.

Responsibilities

• Oversee the clinical trials start-up process from protocol receipt through regulatory approvals and site activation.
• Responsible for data reporting and management, collection of source documents, CRFs, adverse events reporting, and archiving study records.
• Prepare regulatory-related reports and IRB submissions; maintain study binders and ensure compliance with state, federal, and IRB requirements.
• Ensure proper handling, preparation, and shipment of study samples according to protocol and IATA/DOT regulations.
• Coordinate with Protocol Scheduling, Materials Management, Clinical Research Laboratory, Pharmacy, and Research Nursing; assist auditing and monitoring visits.
• Orient and train new staff; provide day-to-day oversight to CRC I and II; contribute to corrective actions as needed.

Skills

Data management

Clinical research

Regulatory knowledge

IRB submissions

Trial coordination

Communication

Education

Bachelor’s degree

Job description

South Shore Health in Weymouth, MA is seeking a Senior Clinical Research Coordinator to support the clinical trials program under the Principal Investigator and Clinical Research Manager. You will lead data collection, management of patient information, and ensure protocol compliance across trials.

The role may involve IRB submissions, regulatory binder maintenance, and occasional travel. Strong organization and communication skills are essential for success in this on-site position.