Senior Clinical Trials Lead & Data Steward

South Shore Health; Weymouth (MA); 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 a clinical trials program. You will ensure accurate data collection, manage patient information, and adhere to Good Clinical Practice under the Principal Investigator and Clinical Research Manager.

The role includes coordinating IRB submissions, assisting with protocol development, and maintaining regulatory binders.

Qualifications

• Bachelor’s degree or 1 year required.
• 3–5 years of medical or scientific research experience preferred.
• Experience in medical or scientific research setting or comparable technology orientated business environment preferred.

Responsibilities

• Oversee study start-up from protocol to site activation and IRB submissions.
• Responsible for data reporting and management, collection of source documents, case report forms, adverse events reporting, filing, and archiving.
• May prepare regulatory related reports and IRB submissions; maintain study binders and regulatory binders; enter data.
• Ensure all study samples are collected, prepared, and shipped according to protocol and IATA/DOT regulations.
• Collaborate with Protocol Scheduling, Materials Management, Clinical Research Laboratory, Pharmacy, and Research Nursing as needed.
• Coordinate internal and external audits and study monitoring visits.
• Manage clinical trials throughout the life cycle and communicate with sponsors and regulatory authorities.
• Close-out trials, contribute to research articles and regulatory communications.
• Interact with study participants as required by protocol and team.
• May collect tissue samples as per trial requirements.

Skills

Data management

ICH/GCP

Regulatory knowledge

IRB submissions

Project coordination

Communication skills

Time management

Education

Bachelor’s Degree

Tools

ONCORE

Job description

South Shore Health in Weymouth, MA is seeking a Senior Clinical Research Coordinator to support a clinical trials program. You will ensure accurate data collection, manage patient information, and adhere to Good Clinical Practice under the Principal Investigator and Clinical Research Manager.

The role includes coordinating IRB submissions, assisting with protocol development, and maintaining regulatory binders.