Senior Internal Clinical Research Associate
S
StrykerMedical Device
United StatesFull-TimeSenior
Salary83,300 - 180,400 USD per year
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Job Details
- Experience
- 2+ years
- Required Skills
- GCP
Requirements
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related scientific discipline.
- Minimum of 2+ years of clinical research experience, preferably within a medical device, biotechnology, pharmaceutical, CRO, or sponsor environment.
- Working knowledge of Good Clinical Practice (GCP), FDA regulations, and clinical research processes.
- Experience supporting clinical study operations, study documentation, and trial execution activities.
- Strong organizational, communication, and project management skills.
- Demonstrated ability to manage multiple priorities in a fast-paced environment.
Responsibilities
- Lead operational execution of assigned clinical studies while ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Serve as a key liaison between internal study teams, field Clinical Research Associates (CRAs), clinical sites, vendors, and external partners to facilitate successful study execution.
- Support the development, review, and maintenance of study documentation, including protocols, informed consent forms, monitoring plans, case report forms, and study-related materials.
- Oversee Trial Master File (TMF) activities to ensure accuracy, completeness, and inspection readiness.
- Develop and maintain study dashboards, trackers, metrics, and reports to support study oversight and decision-making.
- Monitor site performance metrics and collaborate with study teams to proactively identify and resolve operational challenges.
- Support study budget tracking, site payments, vendor invoicing, and financial reconciliation activities.
- Partner cross-functionally with Clinical Program Management, Data Management, Regulatory Affairs, Quality, and Medical Affairs teams to support study objectives.
- Contribute to audit and inspection readiness activities and support responses to regulatory requests.
- Mentor and provide guidance to junior team members while supporting process improvement initiatives that drive operational excellence.
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