We are seeking a Clinical Trial Assistant to be a key member of the Clinical Operations team, responsible for providing administrative and project support for the Clinical Department.

Primary Responsibilities:

• Assist with the auditing and reconciliation of all study-related documents for clinical trials
• Maintain version and quality control of study documentation and submit to Trial Master File
• Assist in the management and conduct quality review of the Trial Master File
• Track the progress of a clinical trial including patient recruitment, trial supplies, and trial documentation
• Accountable for the management of study materials and supplies - distribution, ordering, tracking, storage, reconciliation, and destruction
• Assist with the collection, review, and tracking of regulatory documents and safety data
• Follow established SOPs, ICH-GCP, and other applicable regulatory requirements across all tasks
• Coordinate logistics (including meeting set-up, agendas, and minutes) for the clinical project, program team, regulatory team, and clinical department meetings
• Track and qualify interested Investigators
• Generate and distribute internal and external newsletters
• Generate purchase orders and facilitate contract execution for the department
• Track and process invoices for the department
• Facilitate contract execution for the department
• Develop knowledge and expertise in Therapeutic Area
• Participate in required meetings and workshops
• Build the Sharepoint website and file structure for the department
• Assist with regulatory submissions
• Participate in required meetings and workshops

Competencies:

• Communicates effectively
• Action-oriented
• Tech-savvy
• Good problem-solving skills

Required Skills

• Excellent Microsoft Office skills
• Preferable experience using Microsoft Sharepoint

Education Requirements:

• Bachelor’s Degree: Preferably in a scientific area
• Knowledge of ICH-GCP Guidelines and other regulatory requirements of clinical trial management
• Preferably 2 years of biotechnology or pharmaceutical experience in CRO or sponsor setting

Posted On: Tuesday, January 7, 2025