Assoc Spec, Clinical Research
17011 Red Hill Avenue Irvine, CA 92614 US
Job Description
*Depending on experience
Summary:
The main function of the Associate Clinical Research Specialist, is to perform study start-up and conduct activities, ensuring clinical studies are conducted and reported in accordance with all applicable regulatory requirements. Activities include performing study document review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities.
Key Responsibilities:
• Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit, and other associated supporting tasks)
• Review, identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
• Assist with facilitating recurring study team meetings and external site communications
• Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
• Supports assessments of current processes, identifies opportunities and assists with improving process efficiency within and across related functional areas
• 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
Education and Experience Requirements:
• Bachelor's Degree or equivalent in related field
• 1 year of clinical research experience required
Additional Skills (Preferred):
• Good computer skills in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
• Experience with electronic data capture preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Good understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Strict attention to detail
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