What are the responsibilities and job description for the Senior Clinical Research Specialist position at Cynet Systems?
Job Details
We are looking for Senior Clinical Research Specialist for our client in Irvine, CA
Job Title: Senior Clinical Research Specialist
Job Type: Contract
Job Description:
Pay Range: $54.18hr - $59.18hr
Responsibilities:
- Identify and investigate discrepancies in study documentation by applying clinical protocol and Google Cloud Platform knowledge, and develop processes to mitigate reoccurrence throughout study phases.
- Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good. Documentation Practices, client's internal SOPs, and US and OUS regulations.
- Assess current processes, identify opportunities, and propose solutions to improve process efficiency within and across related functional areas.
- Partner with cross-functional teams (e.g., clinical data management, field teams) with query management, data reviews, and resolution.
- Clinical background, familiar with the clinical study process, monitoring, Google Cloud Platform, and clinical study relevant regulations.
- High compliance requirements and understand that rights and well-being of human subjects should be protected during clinical study.
- Bachelor's Degree or equivalent in a related field.
- 5-7 years of experience required.
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Salary : $54 - $59