Clinical Research Associate II
Company: Stryker
- Location: Mahwah, United States
- Work mode: Hybrid
- Seniority: Mid level
- Employment type: Full-time
- Posted: 2 days ago
- Offer language: English
Job description
Stryker is hiring a Clinical Research Associate II for our Joint Replacement division. This is a hybrid role based in Mahwah, NJ requiring up to 40% travel.
As the Clinical Research Associate II, you will support clinical studies through hands-on site monitoring and study management. In this role, you will serve as a primary contact for clinical research sites and oversee activities across the study lifecycle, helping ensure clinical data integrity and compliance with applicable regulatory requirements, study protocols, and company procedures.
What You Will Do
- Manage assigned clinical research sites throughout the study lifecycle, serving as the primary point of contact for site personnel.
- Conduct site qualification/selection assessments, site initiation, interim monitoring, and closeout visits independently and document findings within required timelines.
- Monitor clinical study data and source documentation to verify accuracy, completeness, traceability, and compliance with study protocols.
- Evaluate site activities against Good Clinical Practice, FDA, ISO, and other applicable clinical research and regulatory requirements.
- Identify, document, and follow up on protocol deviations, data discrepancies, compliance issues, and corrective actions through resolution.
- Coordinate with investigators, clinical research coordinators, study teams, and cross-functional partners to support study execution and address site-level issues.
- Maintain required clinical trial documentation and site records in accordance with study procedures, regulatory requirements, and established quality standards.
- Track site progress, enrollment activities, monitoring findings, and outstanding deliverables to support study timelines and clinical trial objectives.
Required
What You Need
- Bachelor’s degree in a science, healthcare, life sciences, or related field, or equivalent education.
- Minimum 4 years of relevant clinical research experience, including direct clinical site monitoring experience.
- Experience independently conducting site qualification/selection assessments, site initiation, interim monitoring, and/or closeout visits.
- Experience applying Good Clinical Practice, FDA, ISO, or related clinical research requirements to clinical trial activities and documentation.
Preferred
- Certified Clinical Research Associate (CCRA) certification.
- Experience in the medical device or pharmaceutical industry.
- Previous experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Trial Coordinator.
- Experience supporting orthopedic clinical research or orthopedic medical devices.
- US20: $114,800 - $191,400 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. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine 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.


