Internal Clinical Research Associate

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Waltham, MA, 02451, US
Job details
Work flexibility: Onsite Req ID: R574997 Employee type: Full Time Job category: Clinical Affairs Travel: 0% Relocation: No

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Job description

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



Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Click here to learn more about: US Stryker employee benefits

Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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