What are the responsibilities and job description for the Clinical Research Specialist position at Infosoft, Inc.?
Job Title: Clinical Research Specialist
Pay Rate: $52 to $58.95/HR
Duration: 9 months
Location: Irvine, CA (Hybrid)
We are looking for a Sr. Clinical Research Specialist to perform study start-up and conduct activities, including ICF review that meets regulatory requirements, creating study-specific essential document lists, managing and communicating the status of study progress and activities.
- Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge, and develop processes to mitigate recurrence 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, 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 team (e.g., clinical data management, field teams) with query management, data reviews, and resolution
Requirements:
- Bachelor's Degree or equivalent in a related field
- 2-4 years of experience required
- Clinical background, familiar with the clinical study process, monitoring, GCP, and clinical study relevant regulations
- High compliance requirements and understanding that the rights and well-being of human subjects should be protected during clinical study
Salary : $50 - $59