Internal Clinical Research Associate — Study Ops & Compliance

Regulatory Toolkit; Waltham (MA); On-site; USD 87,000 - 145,000; Full time

Job summary

Stryker Corporation in Waltham, MA seeks an Internal Clinical Research Associate to support medical device clinical studies from start-up through closeout. You will handle trial operations, study documentation, device accountability, data review, and regulatory compliance to ensure quality and regulatory standards are met.

The role involves coordinating site activities, maintaining essential study files, and contributing to inspection readiness.

Qualifications

• Bachelor’s degree in Life Sciences or related field required.
• 0+ years of experience in clinical research or trial operations preferred.

Responsibilities

• Support site qualification, activation, monitoring, and closeout across multiple studies.
• Manage investigational device accountability, including serialization, inventory, shipment coordination, and device records.
• Maintain Trial Master Files and essential study documentation for inspection readiness and regulatory compliance.
• Review, organize, and maintain informed consent forms, case report forms, and other study documents.
• Perform remote source data verification and data review to support quality and protocol compliance.
• Develop and maintain study metrics, reports, and dashboards to track progress and performance.
• Coordinate clinical trial registration activities and support audit/inspection preparedness.
• Create communications and documentation to support investigators and cross-functional teams.

Skills

Clinical research experience

GCP knowledge

Data review

Study coordination

Education

Bachelor’s degree in Life Sciences

Tools

Electronic trial databases

Clinical trial management systems

Job description

Stryker Corporation in Waltham, MA seeks an Internal Clinical Research Associate to support medical device clinical studies from start-up through closeout. You will handle trial operations, study documentation, device accountability, data review, and regulatory compliance to ensure quality and regulatory standards are met.

The role involves coordinating site activities, maintaining essential study files, and contributing to inspection readiness.