Clinical Research Associate, Internal (Remote)

United States

Full-time

Remote

$80K/yr - $124K/yr

Entry, Mid Level

Stryker is a company that offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine. They are seeking a Clinical Research Associate to manage administrative aspects of clinical studies, ensuring compliance and data integrity throughout the research process.

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Responsibilities

Establishes and maintains the Clinical Trial Management System (CTMS) and Trial Master File (TMF) in inspection-ready state.
Communicates with assigned sites to drive collection and review essential documents throughout the study, performs QC reviews of study files, including resolution of issues.
Supports development and maintenance of study documents and templates, reviews activities of assigned clinical trials to ensure data integrity and adherence to Federal regulations, company policies, and any other applicable procedures.
Learn device-specific requirements (safety reporting, labeling, IFU tracking).
Provide administrative support and data entry under supervision.
Assist in study start-up (essential documents, site feasibility, initiation prep).
Observe and support site monitoring visits alongside senior CRAs.

Qualification

Required

Bachelor's level degree or equivalent in science or health care field with at least 2 years of relevant clinical research experience.
Working knowledge of GCP and regulatory standards.

Preferred

Experience as a Clinical Research Coordinator, Clinical Trial Coordinator
Developing ability to influence outcomes of assigned tasks including but not limited to area of expertise.