Senior Clinical Trials Coordinator & Data Lead

South Shore Health; South Weymouth (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

South Shore Health seeks a Senior Clinical Research Coordinator to support the clinical research program under ICH/GCP guidelines. You will lead data collection, manage regulatory binders, and ensure protocol adherence across trials, including sample handling and regulatory submissions.

The role involves coordinating with multiple departments, maintaining study documentation, and assisting with audits and monitoring visits. Some travel may be required.

Qualifications

• Bachelor’s Degree or 1 year required.
• 3-5 years of experience in a medical or scientific research setting preferred.
• Excellent organization and communications skills.
• Detail oriented with ability to follow through.

Responsibilities

• Oversee start-up process from protocol receipt to IRB submissions and site activation.
• Data reporting, source document collection, CRF development and adverse events reporting.
• Prepare regulatory reports and maintain study binders.
• Ensure proper sample collection and shipment per protocol and regulations.
• Collaborate with Protocol Scheduling, Materials Management, Pharmacy, and other teams.
• Coordinate internal and external audits and study monitoring visits.
• Manage trial lifecycle communications with sponsors and regulators.
• Support manuscript preparation and regulatory communications.

Skills

ICH/GCP compliance

Regulatory knowledge

SOP understanding

Multi-site study coordination

Data collection and management

Study binder organization

IRB submissions familiarity

Communication skills

Time management

Discretion and confidentiality

Microsoft Office proficiency

Education

Bachelor’s Degree

Tools

ONCORE

Microsoft Office

Job description

South Shore Health seeks a Senior Clinical Research Coordinator to support the clinical research program under ICH/GCP guidelines. You will lead data collection, manage regulatory binders, and ensure protocol adherence across trials, including sample handling and regulatory submissions.

The role involves coordinating with multiple departments, maintaining study documentation, and assisting with audits and monitoring visits. Some travel may be required.