Internal Clinical Research Associate

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

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

Clinical research experience

GCP knowledge

Data review

Study coordination

Educación

Bachelor’s degree in Life Sciences

Herramientas

Electronic trial databases

Clinical trial management systems

Descripción del empleo

Work Flexibility: Onsite

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

Travel Percentage: 0%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.