Clinical Research Specialist (LC18246-1)

Job Description

Job Description

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, Edwards 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

Additional Skills:

• 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

Education and Experience:

• Bachelor's Degree or equivalent in related field

• 2-4 years of experience required

Company Description