Clinical Research Associate, Internal (Remote)
About The Position
The Clinical Research Associate executes all administrative aspects of study management from start-up through close-out under the guidance and mentorship of senior clinical staff. What you will do 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.
Requirements
- Bachelor's level degree or equivalent in science or health care field
- 0-2 years of clinical research experience preferred not required
- Working knowledge of GCP and regulatory standards
Nice To Haves
- Developing ability to influence outcomes of assigned tasks including but not limited to area of expertise.
- Experience as a Clinical Research Coordinator, Clinical Trial Coordinator
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
