Position Title: Clinical Research Specialist Work Location: Irvine, CA 92614 Assignment Duration: 12 Months
Position Summary: The main function of a clinical research specialist is 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.
Key Responsibilities:
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 reoccurrence throughout study phases
Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP 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, our organization 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
Qualification & Experience:
Clinical background, familiar with clinical study process, monitoring, GCP 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 related field
2-4 years of experience required
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $47.00/hr - $51.40/hr.
