Internal Clinical Research Associate

Stryker; Waltham (MA); Presencial; USD 87.000 - 145.000; Jornada completa

Descripción de la vacante

Stryker in Waltham, MA is seeking an Internal Clinical Research Associate to support clinical studies from start-up to closeout. You will contribute to trial operations, device accountability, data review, and regulatory compliance to ensure adherence to quality standards.

Responsibilities include site qualification, monitoring, and closeout, device records maintenance, and creation of study communications for investigators and teams.

Formación

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

Responsabilidades

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

Conocimientos

GCP knowledge

Electronic trial databases

Clinical study coordination

Educación

Bachelor’s degree in Life Sciences

Descripción del empleo

Internal Clinical Research Associate
Waltham, MA

Join a clinical research team that supports the execution of medical device clinical studies from study start-up through closeout. As an Internal Clinical Research Associate, you will contribute to clinical trial operations, study documentation, device accountability, data review, and regulatory compliance activities that help ensure studies are conducted according to established quality and regulatory standards.

What You Will Do

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

What You Will Need

Required Qualifications

• Bachelor’s degree in Life Sciences, or a related scientific discipline.
• 0+ years of experience

Preferred Qualifications

• Experience in clinical research, clinical trial operations, or clinical study administration.
• Experience working under Good Clinical Practice (GCP) guidelines.
• Experience using electronic clinical trial databases, clinical trial management systems, or related research software.
• Experience supporting clinical trial audits, regulatory inspections, or regulatory submission activities.
• Experience with clinical trial registration platforms and study reporting processes.

US20: $87,000 - $145,100 USD Annual